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 .
Applicant’s response (amendments and election) is acknowledged.
Claims 20-29 and new 31-32 are pending after amendment.
The amendments, in part, have raised new issues that are addressed below.
Election/Restrictions-Maintained
Applicant’s election without traverse of the following species in the reply filed on 10/22/24 is acknowledged:
A healthy subject that does not have a dry eye disease or other ocular disease as the ‘reference level’ source per support in para [0021].
Tear film/sample as the ‘test’ source to determine 1., per support in para’s [0030]-[0032]; see also claim 29, where the ‘test’ may be run via step (a) test strip to receive said tear film/sample and (b) a reagent pad comprising an antibody to selectivity bind either histatin 1 or 5.
The previous election of histatin 5 (peptide SEQ ID NO: 5) as the histatin peptide is withdrawn, as the only other histatin peptide claimed, histatin 1 (peptide SEQ ID NO: 1), has been rejoined and both are examined on the merits.
The examiner remains open to interview to advance prosecution on the merits.
Claim Rejections - 35 USC § 103 – Maintained, Modified Based on Amendments
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) 29-30 remain rejected under 35 U.S.C. 103 as being unpatentable over Podoly et al. (U.S. Patent Application No. 20190211380) in view of Kao Corp. (JP 2018124239; 09-08-2018) as to claim 29; and further in view of Incyte Holdings Corp. (ES 256420373, 18-03-2016) as to claim 30.
Podoly teach means for detecting histastins within an analyte sample via antibodies:
BIOMARKER DETECTION
[0032] Analytes can be obtained from many sources including, but not limited to, bodily fluids, cells, swabs, hair, and biopsies. Some aspects provide for analytes obtained from saliva, blood, urine, tears, sweat, nasal, genitals or any other body fluid. An analyte, regardless of source, will have components other than the biomarker or biomarkers to be assayed. Thus, another embodiment of the present invention provides for removal of non-biomarker components from the analyte, wherein the removal is accomplished by treating the sample with at least one antibody that bind at least one analyte component. In some aspects, the at least one antibody is a monoclonal antibody specific for a particular analyte component, or antigen, and is used to bind to the component prior to exposing the analyte to the reaction chamber. The antibody-antigen complex can be removed from the analyte, for example, by centrifugation or filtration. In some aspects of the present invention, the at least one antibody is a polyclonal antibody.
[ ]
27. The method of claim 1 further comprising treating the analyte with at least one antibody that binds at least one analyte component comprising amylases, lysozymes, lipases, proline rich proteins, histatins, cystatins, statherin, or peroxidases, or combinations thereof.
Podoly does not expressly teach that the histatin is histatin 1 or 5 or employing a kit with a test strip and reagent pad.
Kao Corp fills this gap by teaching all of the latter (albeit with saliva rather than tear, but such is interchangeable as shown above in primary reference Podoly), where a protein such as histatin 1 is identified via a kit comprising a test strip whereby an antibody on any type of pad (synonymous with reagent pad) is then used to measure the amount of the protein present in sample:
PNG
media_image1.png
110
484
media_image1.png
Greyscale
PNG
media_image2.png
1040
504
media_image2.png
Greyscale
Neither Podoly nor Kao Corp teach the addition of a further test to assess the subject’s tear film quality or ocular surface health.
Incyte Holdings Corp. fills this gap by teaching any range of dry eye/ADDE disease known tests as options for assessing any/all things tear film/ocular surface health:
Patients who need the treatment for dry eye disease can be identified by a variety of diagnostic methods known in the industry, including diagnostic methods summarized in 35 Bron, et al., "Methodologies to Diagnose and Monitor Dry Eye Disease: Report of the Diagnostic Methodology Subcommittee of the International Dry Eye Workshop (2007) "(" Methodologies, Diagnosis and Monitoring of Dry Eye Disease: Report of the Subcommittee on Diagnostic Methodology of the International Dry Eye Conference (2007) " ), The Ocular Surface, 5 (2), 108-152 (April 2007). These include, but are not limited to: (1) symptom questionnaire (for example, Begley, et al., "Use of the dry eye questionnaire to measure symptoms of ocular irritation in patients with aqueous tear deficient dry eye") of the dry eye questionnaire to measure the symptoms of eye irritation in patients with dry eye due to watery tears deficiency ”, Cornea, 2002: 21: 664-70); (2) coloration of the ocular surface to check the superficial damage (by example rose sparkleror fluorescein staining or other staining method such as those techniques summarized in Barr et al., "Corneal scarring in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study: baseline prevalence and 45 repeatability of detection" ("Corneal Healing Study" in the Collaborative Longitudinal Evaluation of Keratoconus (CLEK): Baseline Prevalence and Detection Repeatability ”, Cornea 1999; 18 (1): 34-46; Lemp," Report of the National Eye Institute / Industry Workshop on clinical trials in dry eyes "(" Report of the National Ocular Institute / Industry Conference on Dry Eye Clinical Trials "), CLAO J 1995; 21 (4): 221-31; Nichols, et al.," The repeatability of clinical measurements of dry eye "," Cornea 2004; 23: 272-85; Bron, et al., "Grading of corneal and conjunctival staining in the context of other dry eye tests" ( Corneal color rating and with juncture in the context of other tests for dry eye ”, Cornea 2003; 22 (7): 640-50); (3) . . .”
Thus, claims 29-30 would have been prima facie obvious over the combination of Podoly in view of Kao Corp and further in view of Incyte Holdings Corp.
Response to Amendments and Arguments
Applicant’s amendments and arguments have been fully considered but are not found persuasive. A product is a product, notwithstanding any intended use or functional language claimed. Under the broadest reasonably interpretation (BRI) of the claim scope, the elements include the following:
Any standard test strip capable of accepting a sample from any bodily fluid – a tear here;
Any receiving element (labeled a ‘reagent pad’; no reagents claimed) for a molecule – here the molecule claimed being an antibody;
Any known antibody engineered to a histatin – here 1 or 5.
These broad-brush elements remain taught and/or suggested by combination
claimed for the reasons of record. Even if not anticipated, such remains prima facie obvious.
A Note on the term ‘Test’: The final limitation to ‘a test’ (claim 30 into claim 29, latter cancelled after last round of amendments) to assess tear or ocular health does not add any new ‘element’ to the kit without more, and thus remains rejected based on the prior art of record using any/all ‘tests’ therein as representative. Under BRI such may simply be ‘a test’ for tear or ocular health carried out with a standard otoscope by the attending practitioner. Arguably, an issue could have been raised but wasn’t as to what falls inside or outside ‘a test’ for such relevant to 35 USC 112(f) – which applicant may proactively address to clarify the record in the next response - re: the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b). Applicant may: (a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f); (b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)). If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either: (a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.]
Prior Art Made of Record But Not Relied Upon – Previously Noted
The prior art cited and relied upon in the related PCT search report & written opinion has been reviewed. The international authority found the instant methods novel and unobvious; however, the national stage examiner here finds other issues, that until resolved, prevent a reasonable search as to what the invention claim scope is intended to encompass relevant to critical/essential elements.
Claim Rejections - 35 USC § 112(b), New, Necessitated by Amendment
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.
Claims 20-28 and 31-32 remain/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.
A new limitation has been added to the claims, where the former ‘reduced’ level of histatin 1 or 5 in the sample versus the reference level has been amended to 2-fold or 5-fold lower level in the context of histatin 1 or 5 versus a reference level. The metes and bounds of either 2-fold or 5-fold is not found adequately defined relevant to the reference level as the preamble is directed to ADDE (aqueous) yet the reference level is not in the context of aqueous levels but merely any dry eye disease whether or not associated with aqueous deficiency or not. Amendment and or clarification on the record is required, as the dialogue with applicant’s representative brought forth that a critical/essential feature of the claimed invention is that it is an aqueous deficiency type of dry eye, e.g. ADDE as opposed to other potential types of dry eye disease as potentially distinguishable.
Claim Rejections - 35 USC § 112(d) – Failure to Further Limit, New,
Necessitated by Amendment
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
New claims 31-32 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. As noted at the outset, new claims 31-32 are not deemed further limiting (35 USC 112(d)) as being drawn to an end result (no further active step or new element claimed; only an end result that is patient dependent and may or may not ever occur). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MAURY A AUDET/Primary Examiner, Art Unit 1654