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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on 21 Aug. 2025 has been entered.
Claims 95-105 and 108-114 are pending and examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restrictions
Applicant’s election of Group II (Claims 95-105), the species anti-inflammatory agent, polyethylene glycol 400 or 8000, dryness, mild, moderate and severe tear deficient dry eye disease, in the reply filed on June 7, 2024 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)).
Claims 106-107 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 7, 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/7/2023, 7/28/2021 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 95-105 and 108-114 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The phrase “at least several hundreds” in claims 95 and 95 is a relative term which renders the claim indefinite. The number of “healthy subjects” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what amount of at least several hundreds encompasses.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 95-105 and 108-114 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez-Avila et al. (2017, J Ocular Pharmacology and Therapeutics, 33: 391-399) in view of Grossman et al. (US 9107906 B1). This is a new rejection.
Sanchez-Avila et al. teaches a method of treating dry eye in patients with primary and secondary Sjogren syndrome with plasma rich growth factor eye drops (Abstract). Inflammation plays a main role in the pathogenesis of dry eye, other therapeutic alternatives such as topical corticosteroids and cyclosporine are used (page 392, paragraph 2). Patient blood was collected and centrifuged and voided of buffy coat that contains leukocytes; supernatant was then heated to reduce immunological components; plasma supernatants were filtered, aliquoted and stored until use (page 392, right column, PRGF preparation). The eye drops were applied topically 4 times daily for 6 weeks in the affected eye. The treatment did not exclude the use of other concomitant treatments (antibiotic agents, anti-inflammatory, artificial tears etc.) when considered necessary (page 393, left column, paragraph 2). The human plasma concentrated would be pooled. The patient has autoantibodies in the sample. The anti-citrullinated protein antibody would be present because the same method and human plasma would contain anti-citrullinated protein antibodies. Citrulline is a non-standard amino acid that can be incorporated into proteins only by post-translational modification of arginine by peptidylarginine deiminase (PAD) enzymes during a variety of biologic processes, including inflammation (see Raptopoulou et al., Abstract). The solution is used for eyes so it is an ocular fluid. Ocular treatment would contain pharmaceutically acceptable ophthalmic excipients because other materials used for eye drops would contain ocular appropriate ingredients such as artificial tears. The treatment for dry eye would be capable of reducing the amount of autoantibodies over the ocular surface; thus, claim 109 is met.
However, Sanchez-Avila et al. does not teach propylene glycol, about 0.1%-99% pooled plasma proteins, about 0.01 mg/mL-1 g/mL pooled IgG, about 0.4%-4% pooled IgG, about 1% pooled IgG, as an intraocular injection, pooled human plasma obtained from at least several hundreds of healthy subjects are not taught.
Grossman et al. teaches a method of providing a composition comprising pooled plasma samples obtained from 1000 or more human subjects (column 2, lines 27-30). Commercially available immunoglobins are derived from pooled human serum to prevent infections in patients (column 1, lines 56-67).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising about 0.1%-99% pooled plasma proteins, about 0.01 mg/mL-1 g/mL pooled IgG, about 0.4%-4% pooled IgG, about 1% pooled IgG of the active agent combination for the following reasons. The reference does teach the composition for treating method of treating dry eye with human plasma. Sanchez-Avila et al. teaches a method of treating dry eye in patients with primary and secondary Sjogren syndrome with plasma rich growth factor eye drops (Abstract Thus, it would have been obvious to make a concentrated composition containing about 0.1%-99% pooled plasma proteins, about 0.01 mg/mL-1 g/mL pooled IgG, about 0.4%-4% pooled IgG, about 1% pooled IgG for use as to treat dry eye. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
The reference also does not specifically teach formulating the composition in the forms claimed by applicant. These pharmaceutical forms are well known in the art to be acceptable means of administering a pharmaceutically active substance. Based on this knowledge, a person of ordinary skill in the art would have had a reasonable expectation that formulating the composition taught by the references in the claimed forms would be successful. Therefore, an artisan of ordinary skill would have been motivated to formulating the composition taught by the reference in the forms claimed by applicant. In addition, while the reference does specifically claim using propylene glycol, the reference does teach using solutions. Propylene glycol is a well known pharmaceutical solution. Thus, a person of ordinary skill in the art would reasonably expect that cornstarch could be used in the composition of the reference. Such reasonable expectation would provide motivation to use propylene glycol.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use pooled human plasma obtained from at least several hundreds of healthy subjects because Grossman et al. teaches a method of providing a composition comprising pooled plasma samples obtained from 1000 or more human subjects (column 2, lines 27-30). Commerically available immunoglobins are derived from pooled human serum to prevent infections in patients (column 1, lines 56-67). One would have been motivated to make pooled plasma for the expected benefit of minimizing infection from pooled human plasma. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Response to Arguments
Applicant argues that Sanchez-Avila et al. does not teach plasma pooled from at least several hundreds of healthy subjects.
In response to Applicant’s argument, Grossman et al. teaches a method of providing a composition comprising pooled plasma samples obtained from 1000 or more human subjects (column 2, lines 27-30). Commerically available immunoglobins are derived from pooled human serum to prevent infections in patients (column 1, lines 56-67). Healthy human subjects are used as donors when there is no infectious disease. One would have been motivated to make pooled plasma for the expected benefit of minimizing infection from pooled human plasma. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand U Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655