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 .
Receipt is acknowledged of IDS filed on 04/18/2022.
Claims 1-19 are pending.
Claims 9-19 are withdrawn.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 1/29/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BOUSQUET (Choroidal Mast Cells in Retinal Pathology A Potential Target for Intervention. The American Journal of Pathology. 2015.).
Regarding claim 1, BOUSQUET teaches a method of measuring mast cells degranulation within an eye (abstract) comprising, administering 48/80 to eyes (page 2085, paragraph 5), specifically rat eyes (page 2084, paragraph 7), which reads on (a) administering a drug to a mammal, wherein the mammal comprises a rat or a mouse. Enucleating the eyes after injection (page 2085, paragraph 5), which reads on (b) enucleating the eyes of the mammal. The retina and anterior segment was removed (page 2085, paragraph 6), which reads on (c) removing the anterior eye and excising the retina from the eye. The choroid was also analyzed for mast cells (page 2085, paragraph 8), which reads on the eye comprises an eyecup that comprises choroidal mast cells (MCs). The mast cell degranulation was observed and imaged (figure 7 and page 2085, paragraph 8), which reads on (d) measuring mast cell degranulation.
Note: Applicant’s specification states the choroid is a part of the eyecup (page 9, paragraph 5 and instant claim 4).
Regarding claims 2 and 3, BOUSQUET teaches administering 48/80 to eyes (page 2085, paragraph 5).
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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over BOUSQUET (Choroidal Mast Cells in Retinal Pathology A Potential Target for Intervention. The American Journal of Pathology. 2015.) in view of BHUTTO (Increased choroidal mast cells and their degranulation in age-related macular degeneration. Br J Ophthalmol. 2016.).
BOUSQUET teaches Applicant’s invention as discussed above. BOUSQUET further teaches that the study is to help determine the causes of ocular inflammation and age-related macular degeneration (AMD), specifically AMD pathogenesis (page 2084, paragraphs 2 and 5).
Furthermore, regarding claim 5-in-part, BOUSQUET teaches counting the choroidal mast cells, including counting degranulated mast cells, which have an irregular shape and extracellular granules (page 2085, paragraph 8).
Regarding claim 4-5, BOUSQUET does not teach staining for non-specific esterase (NSE) activity in mast cells present in the choroid of the eyecup or measuring the non-degranulated mast cells.
Regarding claim 4, BHUTTO teaches a method of determining inflammation in response to AMD by examining mast cells in choroidal cells and specifically the pathological change in AMD (abstract). The method comprises staining the choroid for NSE (page 4, paragraph 1). The stain allowed the mast cells to be examined easily, due to it causing the mast cells to be stained intensely red (page 4, paragraph 2).
Regarding claim 5, BHUTTO teaches both degranulated (DG) and non-degranulated (NDG) mast cells were examined (abstract). Counting both the DG and NDG mast cells allowed for the total amount of mast cells present in the samples to be determined which allowed for precise concentrations of the mast cells to be determined (page 4, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate staining for NSE activity in mast cells present in the choroid. The person of ordinary skill in the art would have been motivated to make those modifications, because the stain assists in identifying and examining mast cells due to it causing the mast cells to be stained intensely red, and reasonably would have expected success because the references are in the same field of endeavor, such as studying eyes for pathological changes of AMD, specifically mast cells, specifically in the choroid.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate measuring the non-degranulated mast cells. The person of ordinary skill in the art would have been motivated to make those modifications, because counting both the DG and NDG mast cells allowed for the total amount of mast cells present in the samples to be determined which allowed for precise concentrations of the mast cells to be determined. This allows for an accurate assessment of how many mast cells are degranulated compared to the whole, and reasonably would have expected success because the references are in the same field of endeavor, such as studying eyes for pathological changes of AMD, specifically mast cells, specifically in the choroid.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over BOUSQUET (Choroidal Mast Cells in Retinal Pathology A Potential Target for Intervention. The American Journal of Pathology. 2015.) and BHUTTO (Increased choroidal mast cells and their degranulation in age-related macular degeneration. Br J Ophthalmol. 2016.) in view of MCLEOD (Distribution and Quantification of Choroidal Macrophages in Human Eyes With Age-Related Macular Degeneration. Retinal Cell Biology. 2016.).
BOUSQUET and BHUTTO teach Applicant’s invention as discussed above.
BOUSQUET further teaches regarding claim 6-in-part, BOUSQUET teaches staining and measuring macrophages (page 2087, paragraph 1 and figure 3).
Regarding claim 6-7, BOUSQUET and BHUTTO do not teach measuring macrophage cell volume and sphericity or staining the macrophages with anti-Iba1 antibody.
Regarding claim 6, MCLEOD teaches a method to study AMD pathogenesis and inflammation and that both mast cells and macrophages are associated with chronic inflammation and AMD (abstract and page 5843, paragraph 2). The study specifically focuses on choroidal macrophages (abstract). The cell volume and sphericity were determined (abstract). Macrophage cell volume and sphericity is measured because these values are indicators of AMD and macrophage activation (page 5847, paragraph 4 and page 5848 paragraph 3), which means these values can determine AMD progression.
Regarding claim 7, MCLEOD teaches staining the macrophages with anti-Iba1 antibody (abstract). This stain helped to measure the macrophage cell volume and sphericity (page 5844, paragraph 7). The amount of IBA1 is also an indicator of AMD (page 5851, paragraph 2), which means this values can determine AMD progression.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate measuring macrophage cell volume and sphericity and staining the macrophages with anti-Iba1 antibody. The person of ordinary skill in the art would have been motivated to make those modifications, because these values are indicators of AMD progression and reasonably would have expected success because the references are in the same field of endeavor, such as studies regarding AMD pathogenesis and inflammation, specifically in the choroid. Furthermore, BOUSQUET teaches staining and measuring macrophages.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over BOUSQUET (Choroidal Mast Cells in Retinal Pathology A Potential Target for Intervention. The American Journal of Pathology. 2015.), BHUTTO (Increased choroidal mast cells and their degranulation in age-related macular degeneration. Br J Ophthalmol. 2016.) and MCLEOD (Distribution and Quantification of Choroidal Macrophages in Human Eyes With Age-Related Macular Degeneration. Retinal Cell Biology. 2016.) in view of MCLEOD 2 (Mast Cell-Derived Tryptase in Geographic Atrophy. Retinal Cell Biology. 2017.).
BOUSQUET, BHUTTO and MCLEOD teach Applicant’s invention as discussed above.
BOUSQUET, BHUTTO and MCLEOD do not teach staining for tryptase with an anti- MC tryptase antibody.
Regarding claim 8, MCLEOD 2 teaches a method to study AMD pathogenesis, specifically mast cells located in the choroid (abstract). The method comprises staining for tryptase with an anti- MC tryptase antibody (page 5889, paragraph 3). Tryptase has a direct effect on AMD progression (5895, paragraph 2).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate staining for tryptase with an anti- MC tryptase antibody. The person of ordinary skill in the art would have been motivated to make those modifications, because the amount of tryptase has a direct effect on AMD progression and can be used to monitor AMD progression and reasonably would have expected success because the references are in the same field of endeavor, such as studies regarding AMD pathogenesis, specifically in the choroid.
Conclusion
No claims are allowable.
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/S.L.M./ Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618