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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submissions filed on 27 June 2025 and 22 July 2025 have been entered.
Status of the Claims
Applicants’ submission filed 27 June 2025 has been entered. Claims 1-3 and 5-7 are pending. Claim 1 has been amended to exclude vascular endothelial cells and hepatocytes from the listed cells. Therefore, claims 1-2 are examined on the merits as being drawn to the elected invention, while claims 3 and 5-7 are withdrawn for reading on the non-elected invention. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 1-2 under 35 USC 102(a)(1) and 35 USC 102(a)(2) over Kumar-Singh et al
Applicants’ amendment to independent claim 1 excluding vascular endothelial cells and hepatocytes from the list of claimed cells obviates the current rejection of record.
Therefore, the rejection is withdrawn.
It is of note that Applicants have failed to make any specific arguments against the disclosure of Kumar-Singh et al in the Remarks filed 27 June 2025.
New Grounds of Rejection
Information Disclosure Statement
The information disclosure statement filed 22 July 2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Interpretation
Claim 1 defines the cell in which the complement is added to within the screening method detailed in instant claim 1 as being a cell produced from a stem cell. This is a product-by-process limitation. Product-by-process limitations are considered only in so far as the method of production affects the structure of the final product. In the instant case, there is no evidence that the cell – or vascular endothelial cell, hepatic sinusoidal endothelial cell, nerve cell, oligodendrocyte, or hepatocyte – produced from a stem cell imparts any particular structure or significance to the listed cells. Thus, the claim will be interpreted as if the addition of a complement to any source of a vascular endothelial cell, a hepatic sinusoidal endothelial cell, a nerve cell, an oligodendrocyte, or a hepatocyte fulfills step (1a) of the instant claim.
Furthermore, in claim 1 the step of ‘selecting a substance that decreases the amount of the cytotoxicity marker’ is interpreted as being a third step (step (3a)).
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar-Singh et al (WO 2012/016162 A2, of record) in view of Nickla et al (Prog Retin Eye Res, 2009).
Kumar-Singh et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2). Nickla et al is considered prior art under 35 USC 102(a)(1).
Regarding claim 1: The instant claim includes product-by-process language. The effect of the product-by-process language is discussed above – see Claim Interpretation – and included herein.
Accordingly, Kumar-Singh et al disclose methods and compositions for identifying potential therapeutic agents for treatment of complement based ocular diseases (Abstract).
As such, Kumar-Singh et al disclose in vitro and in vivo methods of assaying potential therapeutic agents for human macular degeneration (MD), wherein the method includes the contacting of cells with either serum or a complement component 3 (C3) protein, and then administering candidate therapeutic compositions to the contacted cells (Pages 9-10, 12-13, 15-16, 42-44, 54). Kumar-Singh et al further disclose that the contacted cells utilized in the screening of therapeutic compositions have the resulting membrane attack complex (MAC) deposition or ocular endothelial cell proliferation measured – which includes an assessment of Griffonia simplicifolia lectin I (GSL I, an endothelial marker), wherein a reduced amount of marker (i.e. GSL I) reflects the agent is a therapeutic (Pages 10, 14, 16, 36-39, 44-45; Examples 10-12). It is of note that Kumar-Singh et al disclose that the serum in normal human serum, and serves as a complement (Pages 9-10, 86-87; Example 20).
With that, Kumar-Singh et al disclose that the cells contacted with the C3 protein are cells of the eye, including the retina and choroid (Pages 3, 36-37, 40, 46, 49, 96; Examples 11-12, 14, 32; Figures 3-9).
Kumar-Singh et al do not disclose that the contacted cells are neurons, as required by instant claim 1.
Nickla et al, however, disclose that the choroid of the eye comprises intrinsic choroidal neurons that receive sympathetic, parasympathetic, and nitrergic innervation (Abstract; Pages 1, 4-5, 25). Nickla
et al further disclose that there are also neurons in the retina (Pages 14, 19, 21-22).
Therefore, it would have been prima facie obvious to modify the method of Kumar-Singh et al such that the retinal and internal choroidal neurons are contacted with the C3 protein. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to ensure that all cells of the tested ocular tissue are treated with the complement and candidate therapeutic, and would have had a reasonable expectation of success since Kumar-Singh et al disclose the treatment of the retina and choroid, and even reference the layers of neurons within the retina in Example 14 (Pages 3, 36-37, 40, 46, 49, 96; Examples 11-12, 14, 32; Figures 3-9). See MPEP § 2143(I)(G).
Consequently, Kumar-Singh et al as modified by Nickla et al render obvious methods for assaying potential therapeutic agents for the treatment of human macular degeneration, wherein nerve cells of the retina or choroid are contacted with a C3 protein (a complement) and a candidate therapeutic composition (therapeutic drug candidates), and wherein the resulting membrane attack complex (MAC) deposition or ocular endothelial cell proliferation via GSL I expression (cytotoxic markers) is measured. This therefore renders obvious the method of the instant claim.
Regarding claim 2: Following the discussion of claim 1, Kumar-Singh et al further disclose the addition of anti-mouse emmprin antibody followed by exposure to normal human serum (NHS) (Pages 11, 26, 55, 86-87, 96). With that, Kumar-Singh et al further disclose in an exemplary embodiment the contacting of CD46-pretreated cells with anti-mouse emmprin antibody immediately followed by exposure to normal human serum (Pages 86-87, Example 20). It is of note that human CD46 is considered a therapeutic (Page 46) and anti-mouse emmprin antibody is a complement activating factor (Pages 24, 86).
This therefore reads on the method of the instant claim, as the broadest reasonable interpretation of the method allows for the steps to be completed in any order. See MPEP § 2111.01(II). More specifically, step (2a) requiring the treatment of the cells with CD46 is performed before step (1a), or the treatment of the cells with the complement activation factor and complement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633