DETAILED ACTION
Applicant’s amendment and Arguments/Remarks received on 23 March 2026 have been entered. Claims 1-9, 12-14, 16-24, 27, and 32 were previously pending in the application. Claims 12 and 23 have been cancelled, and no new claims have been added by Applicant. Claims 1-9, 13-14, 16-22, 24, 27, and 32 are currently pending in the application. Claims 1 and 14 are independent claims.
The following election of species remains in effect in the instant application:
Heavy chain amino acid sequences: a. SEQ ID NO: 2;
Light chain amino acid sequences: a. SEQ ID NO: 1;
Cell type: l. retinal pigment epithelial cells.
Claims 6-7 and 19-20 remain withdrawn from consideration as being directed to a nonelected species, there being no allowable generic or linking claim.
Claims 1-5, 8-9, 13-14, 16-18, 21-22, 24, 27, and 32 are currently pending and under examination in the instant application. An action on the merits follows.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2020/047733, filed 25 August 2020, which claims priority to U.S. Provisional Application Nos. 62/891,799, filed 26 August 2019, 62/902,352, filed 18 September 2019, and 63/004,258, filed 02 April 2020. Thus, the earliest possible priority for the instant application is 26 August 2019.
However, as discussed in the prior action, the limitations previously presented in claims 12-13 and 23-24 are not entitled to the benefit of the prior applications 62/891,799 and 62/902,352 and thus have an effective filing date of 02 April 2020. Given the incorporation of the limitations of cancelled claims 12 and 23 into independent claims 1 and 14 in the current amendment filed 23 March 2026, respectively, the effective filing date of 02 April 2020 for the limitation “wherein the method further comprises, after the administering step, a step of monitoring the post ocular injection thermal profile of the composition in the eye using an infrared thermal camera” now applies to all claims. Claims 17 and 32 are not entitled to the benefit of the prior applications 62/891,799, 62/902,352, and 63/004,258 and thus have an effective filing date of 25 August 2020. Claims 1-5, 8-9, 14, 16-18, and 21-22 are entitled to the benefit of the prior applications with an effective filing date of 26 August 2019.
37 CFR 1.821-1.825
Applicant’s amendments to the specification filed 23 March 2026 have inserted the appropriate SEQ ID NOs for the sequences or removed the sequences recited in at least paragraph [0073] section (iv) on page 34 (e.g., EDTAVY94Y95 and EDFATY86), [00122] section (ii) on page 57 (e.g., TVSWN165SGAL, QSGN158SQE, and TFFQ100GT) and section (iv) on page 57 (e.g., EDTAVYY and EDFATY), and [0193] (e.g., RKRR, RRRR, RRKR, RKKR) of the instant specification and within the Brief Description of the Drawings in paragraphs [0101] and [0103] for Figures 1 and 3 of the instant drawings, which are now in compliance with 37 CFR 1.821-1.825.
Specification
The objection to the specification of the disclosure for the Brief Description of the Drawings not including a description of each panel, for an apparent typographical error, and for reciting trade names or marks used in commerce without the appropriate symbols, capitalization, and/or generic terminology, is withdrawn in view of the amendment to the specification. The amendment to the specification of the disclosure filed 23 March 2026 has been entered.
Claim Objections
The objection to amended claims 1, 3-5, 14, and 16-18 for bold font formatting and recitation of “DR” without first writing out the term for which DR is an abbreviation is withdrawn in view of the amendment to the claims.
The objection to amended claims 8 and 21 for recitation of “CB7” without first writing out the term for which CB7 is an abbreviation is withdrawn in view of the amendment to the claims.
**The following new objection is necessitated by amendments to the claims.
Amended claims 9 and 22 are newly objected to because of the following informalities: amended claims 9 and 22 each recite “CDR” without first writing out the term for which “CDR” is an abbreviation. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The rejection of amended, previously presented, and cancelled claims 9, 12-13, and 22-24 under 35 U.S.C. 112(b) as failing to particularly point out and distinctly claim the subject matter which the inventor(s) regards as the invention for multiple issues of indefiniteness is withdrawn over cancelled claims 12 and 23, withdrawn over amended claims 9 and 22, and maintained over claims 13 and 24 in view of Applicant’s cancellation of claims 12 and 23 and amendments to the claims. Applicant's amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
Applicant amended claims 13 and 24 to recite “FLIR® T530”, and as such, both claims still recite a trademark/trade name. As discussed in the prior action, where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an infrared thermal camera and, accordingly, the identification/description is indefinite. Mere addition of the appropriate symbol for a trade name and/or mark does not render the claim definite.
MPEP 608.01(v)(I) states, “A mark as defined by 15 U.S.C. 1127 (i.e., trademark, service mark, collective mark, or certification mark) or trade name may be used in a patent application to identify an article or product, service, or organization if:
(A) its meaning is established by an accompanying definition in the specification which is sufficiently descriptive, enabling, precise and definite such that a claim including the mark or trade name complies with the requirements of 35 U.S.C. 112, or
(B) its meaning is well-known to one skilled in the relevant art and is satisfactorily defined in the literature.
See, e.g., United States Gypsum Co. v. National Gypsum Co., 74 F.3d 1209, 1214 n.6, 37 USPQ2d 1388, 1392 n. 6 (Fed. Cir. 1996). Condition (A) or (B) must be met at the time of filing of the complete application.
The relationship between a mark or trade name and the product, service, or organization it identifies is sometimes indefinite, uncertain, and arbitrary. For example, the formula or characteristics of a product may change from time to time and yet it may continue to be sold under the same mark or trade name. In patent specifications, the details of the product, service, or organization identified by a mark or trade name should be set forth in positive, exact, intelligible language, so that there will be no uncertainty as to what is meant. Arbitrary marks or trade names which are liable to mean different things at the pleasure of the owner do not constitute such language. Ex Parte Kattwinkle, 12 USPQ 11 (Bd. App. 1931).”
In the instant case, the specification merely refers to the trade name “FLIR® T530” as an infrared thermal camera [00100, 00347, 00350], and as such, the meaning of the trade name “FLIR® T530” has not been described in the specification sufficiently to establish its meaning by an accompanying definition in the specification which is sufficiently descriptive, enabling, precise and definite such that a claim including the mark or trade name complies with the requirements of 35 U.S.C. 112. Further, the meaning of the mark is not sufficiently well-known and described in the relevant art nor satisfactorily defined in the literature in a way to precisely define the structure claimed and to preclude any product changes over time.
Therefore, the metes and bounds of the claims sill cannot be determined.
Applicant argues that the amendment to claims 13 and 24 address the rejection. However, this is not agreed. As discussed above, merely adding the ® mark to a trade name and/or mark does not render the claim definite.
Applicant’s amendments and arguments are not sufficient to overcome a finding of indefiniteness under 35 U.S.C. 112(b).
**The following new rejection is necessitated by amendments to the claims.
Amended claims 9 and 22 are newly 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.
Amended claims 9 and 22 each recite, wherein the anti-hVEGF antibody, or antigen-binding fragment thereof, comprises features recited as (A), or (B), or (C):
“(A) light chain CDRs 1-3 consisting of amino acid sequences of SASQDISNYLN (SEQ ID NO: 14), FTSSLHS (SEQ ID NO: 15), and QQYSTVPWT (SEQ ID NO: 16), respectively, and heavy chain CDRs 1- 3 consisting of amino acid sequences of GYDFTHYGMN (SEQ ID NO:20), WINTYTGEPTYAADFKR (SEQ ID NO: 18), and YPYYYGTSHWYFDV (SEQ ID NO: 21), respectively; or
(B) a heavy chain variable region consisting of amino acids 1-123 of SEQ ID NO:2, and a light chain variable region consisting of amino acids 1-107 of SEQ ID NO:1; or;
(C) a heavy chain consisting of the amino acid sequence of SEQ ID NO:2, and a light chain consisting of amino acid sequence of SEQ ID NO:1”;
which is indefinite because the three options are recited in the alternative even though (A) and (B) are each inherent features of the sequences of SEQ ID NOs: 1 or 2 recited as required to be comprised by the anti-hVEGF antibody/antibody fragment in independent claims 1 and 14 and do not further limit the nucleic acid sequence encoding the anti-hVEGF. Additionally, the features recited in (A) and (B) on their own are broader than the limitation recited in claims 1 and 14 that the anti-hVEGF antibody/antibody fragment comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 2 (as elected), and a light chain comprising the amino acid sequence of SEQ ID NO: 1 (as elected).
Additionally, by reciting “nucleic acid sequences encoding heavy and light chains of the anti-hVEGF antibody, or antigen-binding fragment thereof” in lines 4-5 and “wherein the anti-hVEGF antibody, or antigen-binding fragment thereof” in lines 6-7, claim 22 is reciting a limitation which is broader than the limitation of independent claim 14, upon which it depends, which recites that the expression vector encodes “an anti-human vascular endothelial growth factor (hVEGF) antibody fragment” in lines 3-4.
As such, the metes and bounds of the claim cannot be determined.
Claim Rejections - 35 USC § 112(a)- New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
**The following new rejection is necessitated by amendments to the claims.
Amended claims 9 and 22 are newly rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The Applicant is reminded that an amendment to the claims or the addition of a new claim must be supported by the description of the invention in the application as filed. In re Wright, 866 F.2d 422, 9 USPQ2d 1649 (Fed. Cir. 1989). New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972).
Claims 9 and 22 were each amended to recite, “a light chain variable region consisting of amino acids 1-107 of SEQ ID NO:1” in lines 15-16 of each claim. However, the instant disclosure does not provide any teachings, explicitly or implicitly, to support this new limitation. The specification does not recite any teachings related to the sequence bounds of the light chain variable region of amino acids in SEQ ID NO: 1 beyond merely reciting that the variable region comprises the CDRs 1-3, which together do not constitute the full sequence of amino acids 107 of SEQ ID NO: 1 [0200]. The drawings provide an annotated version of SEQ ID NO: 1 in Figure 1, wherein an arrow followed by “VL” and an arrow followed by “CL” indicate the start (i.e., N-terminal end) of the variable and constant regions, respectively. Figure 1 indicates that the constant region begins with T109, and as such, that the variable region ends with R108 and not with K107. Therefore, a light chain variable region which consists of amino acids 1-107 of SEQ ID NO: 1 is not supported in the original disclosure as filed, and the limitation represents new matter.
Claim Rejections - 35 USC § 102
The rejection of amended and previously presented claims 1-5, 8-9, 14, 16-18, and 21-22 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Simpson et al. (US20190127455A1), published 2 May 2019, filed 14 April 2017, with priority to U.S. Provisional Application No. 62/323,285, filed 15 April 2016, IDS, is withdrawn in view of Applicant’s claims which now recite “wherein the method further comprises, after the administering step, a step of monitoring the post ocular injection thermal profile of the composition in the eye using an infrared thermal camera” in lines 11-13 of independent claim 1 and lines 9-11 of independent claim 14.
The rejection of amended and previously presented claims 1-5, 8-9, 14, 16-18, and 21-22 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tretiakova & Wilson (US20190381194A1), published 19 December 2019, filed 14 April 2017, with priority to U.S. Provisional Application No. 62/323,184, filed 15 April 2016, IDS, is withdrawn in view of Applicant’s claims which now recite “wherein the method further comprises, after the administering step, a step of monitoring the post ocular injection thermal profile of the composition in the eye using an infrared thermal camera” in lines 11-13 of independent claim 1 and lines 9-11 of independent claim 14.
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.
Amended and previously presented claim(s) 1-5, 8-9, 13-14, 16-18, 21-22, 24, 27, and 32 are newly rejected under 35 U.S.C. 103 as being unpatentable over Tretiakova & Wilson [US20190381194A1, published 19 December 2019, filed 14 April 2017, with priority to U.S. Provisional Application No. 62/323,184, filed 15 April 2016, IDS], cited in a prior action; in view of Orlov et al. [2013, Modern Technologies in Medicine, 5(3), 69-72]; Tan et al. [2009, Infrared Physics & Technology, 52, 97-108, cited in a prior action]; and FLIR [2017, FLIR Press Releases: FLIR Launches Ergonomic Professional Thermography Camera Series, retrieved on 20 May 2026 from: <https://www.flir.com/news-center/press-releases/flir-launches-ergonomic-professional-thermography-camera-series/>, published 09 May 2017].
Regarding independent claims 1 and 14, Tretiakova teaches a method of treating a human subject diagnosed with diabetic retinopathy (DR) [0087-0088, 0092], comprising administering to the subretinal space of the eye of said human subject [0012, 0026, 0074, 0109] an expression vector encoding an anti-human vascular endothelial growth factor (hVEGF) antigen-binding fragment/ antibody fragment (Fab) [0029, 0109], wherein the anti-hVEGF antigen-binding fragment/antibody fragment (Fab) comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 1, which is the same length as and has 100% sequence identity with instant SEQ ID NO: 2 [0029, 0045] and a light chain comprising the amino acid sequence of SEQ ID NO: 2, which is the same length as and has 100% sequence identity with instant SEQ ID NO: 1 [0029, 0045], and wherein the expression vector is an AAV8 vector [0014, 0026, 0060, 0109].
Alignment of instant SEQ ID NO: 2 with Tretiakova SEQ ID NO: 1:
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323
498
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Alignment of instant SEQ ID NO: 1 with Tretiakova SEQ ID NO: 2:
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313
500
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Tretiakova also teaches to monitor the injected material using SD-OCT retinal microscopy, with near infrared (NIR) reflectance (REF), and with NIR fundus autofluorescence using a scanning laser ophthalmoscope [0101, 0203, 0296], and that infrared spectral domain optical coherence tomography images show the boundaries of the injection site [0021-0023, Figure 6, 7, 8].
Tretiakova does not teach a step of monitoring the post ocular injection thermal profile of the injected material in the eye using an infrared thermal camera.
However, Orlov teaches postoperative monitoring by infrared radiothermometry to study ocular surface temperature following alloplant transplantation for choroidal revascularization in patients with age-related macular degeneration [abstract]. Orlov also teaches IR thermometry was able to observe increases in temperature of the operated eyes and changes in the asymmetry due to reactive inflammation 5 days following surgery, which resolved by the 40th day of follow-up, such that the IR radiothermometry findings demonstrate a number of temperature regularities characteristic of choroidal revascularization operations [abstract, page 71 column 1 ¶ 3]. Orlov additionally teaches using IR radiothermometry to assess the efficiency of the choroidal revascularization operations [page 69, column 2 ¶ 2]. Orlov further teaches that the advantages of IR-radiothermometry are remotability, noncontact character, absolute safety, and the possibility of multiple follow-up [page 69, column 2 ¶ 1], wherein the possibility of real-time monitoring of the eye temperature asymmetry change offers the opportunities of individual monitoring of early and long-term postoperative period when using revascularization technologies, and wherein the results show the application of IR radiothermometry for dynamic control of immediate and long-term results and recovery time control in biomaterial transplantation for retinal blood supply correction in degenerative age-related changes [page 71 column 1 ¶ 4-5]. Orlov also teaches that they used a portable microprocessor-based IR-radiothermometer [page 69 column 2 ¶ 4- page 70 column 1 ¶ 1; Figure 1]. Therefore, given the teachings of Orlov to use IR radiothermometry to monitor the surface temperature of the eye following ocular retinal surgery such that postoperative inflammation and healing processes were observed in real-time without needing to contact the eye directly, an ordinarily skilled artisan would have been motivated to include a step of monitoring the post ocular surgery thermal profile of a composition implanted/injected into the eye using an infrared detector to monitor the inflammation and/or healing processes over time.
Orlov does not teach that the IR detector is an infrared thermal camera.
However, Tan teaches that thermal imaging (thermography) is a non-invasive imaging procedure used to record the thermal patters using an IR camera which provides visual and qualitative documentation of temperature changes in the vascular tissues, and is beginning to play an important role in the field of ophthalmology [abstract]. Tan further teaches that IR thermography has been applied to ophthalmology to diagnose eye diseases and is renowned for its ability to detect the pathological and physiological changes in the eye which are obscured or unreachable under anatomical examination [page 98 column 1 ¶ 4; page 98 column 2 ¶ 2]. Tan also teaches that IR thermometry and thermography each can measure OST without causing trauma on subjects, without altering the surface temperature, and with high precision, and that IR thermography specifically provides the distribution of temperature in a 2D distribution unlike IR thermometry which gives only a single temperature value [page 98 column 2 ¶ 4]. Therefore, an ordinarily skilled artisan would have been motivated to use an IR thermal camera to capture a 2D thermal profile of the ocular surface to observe a temperature distribution of ocular surface temperature.
Regarding claim 2, Tretiakova discloses wherein the administering to the subretinal space of the eye of the human subject is by injecting the expression vector into the subretinal space using a subretinal drug delivery device (e.g., the delivery is automated via the vitrectomy machine to deliver 250 µl to the subretinal space with a 38 gauge subretinal cannula) [0094, 0017].
Regarding claims 3-5 and 16-18, Tretiakova teaches wherein the administering delivers a therapeutically effective amount of the anti-hVEGF antigen-binding fragment/ antibody fragment (Fab) to the retina of said human subject [0014, 0093], and wherein the therapeutically effective amount of the anti-hVEGF antigen binding fragment/antibody fragment is produced by human retinal cells of said human subject, including retinal epithelial cells [0060, 0344].
Regarding claims 8 and 21, Tretiakova discloses wherein the expression vector comprises a CMV enhancer/chicken β-actin promoter (CB7) promoter [0016-0017, 0052, 0113, Figure 1].
Regarding claims 9 and 22, Tretiakova teaches that the expression vector is an AAV8.CB7.aVEGF vector, which is an AAV8 vector genome containing an expression cassette flanked by the AAV2 inverted terminal repeats (ITRs) [0007, 0016, Figure 1]. Tretiakova also teaches that the expression cassette comprises (i) nucleic acid sequences encoding human anti-vascular endothelial growth factor (anti-VEGF) antigen binding antibody fragment (Fab), wherein the nucleic acid sequences coding for the heavy and light chains of anti-VEGF Fab are separated by a self-cleaving furin (F)/F2A linker; and (ii) control elements including the CB7 promoter consisting of the chicken β-actin promoter and CMV enhancer, a chicken β-actin intron, and a rabbit β-globin polyA signal [0007, 0016, Figure 1].
As discussed above, Tretiakova teaches wherein the anti-VEGF Fab comprises a heavy chain comprising the amino acid sequence of instant SEQ ID NO: 2 and a light chain comprising the amino acid sequence of instant SEQ ID NO: 1, and as such, Tretiakova teaches wherein the light chain CDRs 1-3 consist of amino acid sequences according to instant SEQ ID NOs: 14-16 and wherein the heavy chain CDRs 1-3 consist of amino acid sequences of instant SEQ ID NOs: 20, 18, and 21, which are comprised within instant SEQ ID NOs: 1 and 2, respectively. Although Tretiakova does not identify the identical sequences as the CDRs for the heavy and light chain variable regions, the heavy and light chain sequences are identical, and as such, will have identical functional properties.
Tretiakova further teaches wherein the heavy (VH) and light (VL) chain variables regions correspond to nucleic acids 2059-2427 and 2896-3216 of SEQ ID NO: 3, respectively [0033, specification page 47-48 sequences listing annotation for SEQ ID NO: 3], which encode sequences which have the same length as and 100% identity to amino acids 1-123 and 1-107 of SEQ ID NO: 1 (instant SEQ ID NOs: 2) and SEQ ID NO: 2 (instant SEQ ID NO: 1), respectively [specification page 49-51 annotated sequence listing].
Tretiakova additionally teaches wherein the heavy chain consists of the amino acid sequence of SEQ ID NO: 1 (with the same length and 100% identity to instant SEQ ID NO: 2) and the light chain consists of the amino acid sequence of SEQ ID NO: 2 (with the same length and 100% identity to instant SEQ ID NO: 1) [0029, 0045, specification page 49 -50 displaying the translation of SEQ ID NO: 3 encoding SEQ ID NOs: 1 and 2].
Regarding claims 13 and 24, FLIR teaches that the FLIR® T530 professional thermal imaging camera is designed for thermographers who work in a variety of environments including research laboratories and have intelligent lenses that produce crisp imagery and use laser distance measurement data during autofocus to achieve high temperature measurement accuracy [page 1 ¶ 1-2]. FLIR also teaches that with resolutions up to 464 x 348 and superior sensitivity and image clarity, thermographers can identify subtle temperature differences aided by a 4-inch touchscreen display that is four times the resolution of comparable cameras. Therefore, given the teachings of FLIR of the benefits of the FLIR® T530 infrared thermal camera, including the ability to identify subtle temperature differences, an ordinarily skilled artisan would have been motivated to use the FLIR® T530 camera as the infrared thermal camera of choice.
Regarding claims 27 and 32, Tretiakova teaches that clinical objectives are determined by performing vector shedding analysis in serum and urine [0166, 0275, 0366]. Tretiakova also teaches that shedding of the AAV8.aVEGF test vector was determined by quantitative PCR (qPCR) analysis targeting transgene-specific sequences in samples of tears, nasal secretion, serum, saliva, urine, and feces, and that the AAV8.aVEGF test vector DNA was readily detectable in most samples collected from animal administered AAV8 [0318]. Tretiakova further teaches that the presence of AAV8.aVEGF DNA was dose-dependent, transient, and decreased over time [0318]. By teaching that only “most” samples had readily detectable vector DNA and that the presence of AAV8.aVEGF DNA was transient, Tretiakova teaches that the expression vector DNA was undetectable by qPCR at some point after administration.
Given the motivation taught by Orlov to include a step of monitoring the post ocular surgery thermal profile of a composition implanted/injected into the eye using an infrared detector to monitor the inflammation and/or healing processes over time; the motivation taught by Tan to use an IR thermal camera to capture a 2D thermal profile of the ocular surface to observe a temperature distribution of ocular surface temperature; and the motivation taught by FLIR to use the FLIR® T530 camera as the infrared thermal camera of choice; it would have been prima facie obvious to an ordinarily skilled artisan at the time of filing the instant application to modify the method of Tretiakova to include a step of monitoring the post ocular injection thermal profile of the composition in the eye using an infrared thermal camera with a reasonable expectation of success.
Double Patenting
The provisional rejection of amended, previously presented, and cancelled claims 1-5, 8-9, 12-14, 16-18, 21-24, 27, and 32 on the ground of nonstatutory double patenting as being unpatentable over claims 12, 24-34, and 38-63 of copending Application No. 16/971,215, hereafter referred to as the ‘215 application is withdrawn over cancelled claims 12 and 23 and maintained in modified form over amended and previously presented claims 1-5, 8-9, 13-14, 16-18, 21-22, 24, 27, and 32, in view of the ‘215 application now be issued as U.S. Patent No. 12,558,434.
Amended and previously presented claims 1-5, 8-9, 13-14, 16-18, 21-22, 24, 27, and 32 are now rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 12,558,434, hereafter referred to as the ‘434 patent, in view of Orlov et al. [2013, Modern Technologies in Medicine, 5(3), 69-72]; Tan et al. [2009, Infrared Physics & Technology, 52, 97-108, cited in a prior action]; and FLIR [2017, FLIR Press Releases: FLIR Launches Ergonomic Professional Thermography Camera Series, retrieved on 20 May 2026 from: <https://www.flir.com/news-center/press-releases/flir-launches-ergonomic-professional-thermography-camera-series/>, published 09 May 2017]. Applicant's amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
Applicant amended independent claims 1 and 14 to incorporate limitations from cancelled claims 12 and 23, respectively. The only new limitations introduced into independent claims 1 and 14 is the addition of “or antigen-binding fragment” thereof, which broadens the scope of the claim, and limiting “antibody” to “antibody fragment” in claim 14.
Independent claims 1 and 14 newly recite, “wherein the method further comprises, after the administering step, a step of monitoring the post ocular injection thermal profile of the composition in the eye using an infrared thermal camera”. Although this limitation is not recited by the ‘434 patent claims, it represents an obvious embodiment of the ‘434 patent claims, as taught by Orlov, Tan, and FLIR.
Orlov teaches postoperative monitoring by infrared radiothermometry to study ocular surface temperature following alloplant transplantation for choroidal revascularization in patients with age-related macular degeneration [abstract]. Orlov also teaches IR thermometry was able to observe increases in temperature of the operated eyes and changes in the asymmetry due to reactive inflammation 5 days following surgery, which resolved by the 40th day of follow-up, such that the IR radiothermometry findings demonstrate a number of temperature regularities characteristic of choroidal revascularization operations [abstract, page 71 column 1 ¶ 3]. Orlov additionally teaches using IR radiothermometry to assess the efficiency of the choroidal revascularization operations [page 69, column 2 ¶ 2]. Orlov further teaches that the advantages of IR-radiothermometry are remotability, noncontact character, absolute safety, and the possibility of multiple follow-up [page 69, column 2 ¶ 1], wherein the possibility of real-time monitoring of the eye temperature asymmetry change offers the opportunities of individual monitoring of early and long-term postoperative period when using revascularization technologies, and wherein the results show the application of IR radiothermometry for dynamic control of immediate and long-term results and recovery time control in biomaterial transplantation for retinal blood supply correction in degenerative age-related changes [page 71 column 1 ¶ 4-5]. Orlov also teaches that they used a portable microprocessor-based IR-radiothermometer [page 69 column 2 ¶ 4- page 70 column 1 ¶ 1; Figure 1]. Therefore, given the teachings of Orlov to use IR radiothermometry to monitor the surface temperature of the eye following ocular retinal surgery such that postoperative inflammation and healing processes were observed in real-time without needing to contact the eye directly, an ordinarily skilled artisan would have been motivated to include a step of monitoring the post ocular surgery thermal profile of a composition implanted/injected into the eye using an infrared detector to monitor the inflammation and/or healing processes over time.
Additionally, Tan teaches that thermal imaging (thermography) is a non-invasive imaging procedure used to record the thermal patters using an IR camera which provides visual and qualitative documentation of temperature changes in the vascular tissues, and is beginning to play an important role in the field of ophthalmology [abstract]. Tan further teaches that IR thermography has been applied to ophthalmology to diagnose eye diseases and is renowned for its ability to detect the pathological and physiological changes in the eye which are obscured or unreachable under anatomical examination [page 98 column 1 ¶ 4; page 98 column 2 ¶ 2]. Tan also teaches that IR thermometry and thermography each can measure OST without causing trauma on subjects, without altering the surface temperature, and with high precision, and that IR thermography specifically provides the distribution of temperature in a 2D distribution unlike IR thermometry which gives only a single temperature value [page 98 column 2 ¶ 4]. Therefore, an ordinarily skilled artisan would have been motivated to use an IR thermal camera to capture a 2D thermal profile of the ocular surface to observe a temperature distribution of ocular surface temperature.
FLIR teaches that the FLIR® T530 professional thermal imaging camera is designed for thermographers who work in a variety of environments including research laboratories and have intelligent lenses that produce crisp imagery and use laser distance measurement data during autofocus to achieve high temperature measurement accuracy [page 1 ¶ 1-2]. FLIR also teaches that with resolutions up to 464 x 348 and superior sensitivity and image clarity, thermographers can identify subtle temperature differences aided by a 4-inch touchscreen display that is four times the resolution of comparable cameras. Therefore, given the teachings of FLIR of the benefits of the FLIR® T530 infrared thermal camera, including the ability to identify subtle temperature differences, an ordinarily skilled artisan would have been motivated to use the FLIR® T530 camera as the infrared thermal camera of choice.
As such, it would have been obvious to an ordinarily skilled artisan at the time of filing the instant application to modify the method of the ‘434 patent claims to include a step of monitoring the post ocular injection thermal profile of the composition in the eye using an infrared thermal camera. Accordingly, the ‘434 patent claims encompass and render obvious instant claims 1-5, 8-9, 13-14, 16-18, 21-22, 24, 27, and 32.
The Applicant requests that the rejection be held in abeyance until the indication of allowable subject matter. However, the instant rejection may not be held in abeyance. As set forth in MPEP 804, only objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance until allowable subject matter is indicated. A complete response to a nonstatutory double patenting (NDP) rejection is either a reply by Applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (MPEP 804 (I)(B)(1)). Such a response is required even when the nonstatutory double patenting rejection is provisional.
Therefore, Applicant’s arguments do not overcome the nonstatutory double patenting rejection over the ‘434 patent.
The provisional rejection of amended, previously presented, and cancelled claims 1-5, 8-9, 12-14, 16-18, 21-24, 27, and 32 on the ground of nonstatutory double patenting as being unpatentable over claims 5-10, 15-18, 23-25, 34-38, and 41 of copending Application No. 17/600,377, hereafter referred to as the ‘377 application is withdrawn in view of the ‘377 application now being abandoned.
Conclusion
No claim is allowed.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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