DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Preliminary Amendment
Receipt is acknowledged of the preliminary amendment filed on 6/4/2025, 8/18/2025. The amendment has been placed of record in the file.
The Information Disclosure Statements
The prior art cited in the information disclosure statements filed on 8/18/2025 has been considered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 27-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-1-11 of U.S. Patent No. 12,329,457 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the Patent claims anticipate the instant claims.
Instant claims correspond to the Patent claims as follows:
19/228,322
12,329,457 B2
27-31, 43, 46
1
32
1
33, 34, 35
2, 3, 4, respectively
36, 45, 47
5
37, 38, 39, 40
6, 7, 8, 9, respectively
41, 48
10
42, 45
11
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) 27-31, 35-37, 42, 46-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuschel (US 2008/0272312 A1), in view of Levenson et al. (US 2008/0074649) [hereinafter Levenson].
As to claims 27-31, 37, 46,Tuschel teaches a method for determining whether a subject has or is predisposed for developing a disorder associated with amyloidopathy or amyloidosis, the method comprising: obtaining spectral data over a range of wavelengths from light reflected by a tissue of a subject (paragraphs 0038, 0040, 0043; Fig.6); and analyzing the spectral data at multiple light bands over the range of wavelengths (paragraph 0043, claims 5-10).
Tuschel is silent to ‘to determine whether the spectral data is indicative of at least one of amyloidopathy or amyloidosis or a predisposition to at least one of amyloidopathy or amyloidosis in the subject.’
However, Levenson, in the same field of endeavor, teaches sample imaging and classification comprising detection and characterization of amyloid (paragraphs 0161, 0165).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to detect and characterize a sample containing amyloid in order to provide proper treatment regimen to proper amyloid disease (paragraphs 0165, 0161, 0165).
Still Tuschel is silent that said tissue is eye tissue. However, Tuschel discloses a system and method to detect diseased portion of a biological tissue, and thus tissue type is incidental- the material upon which an apparatus acts is incidental to the claimed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to use Tuschel system to investigate eye tissue in order to determine/detect diseased portion of a biological tissue.
As to claim 31, Tuschel in view of Levenson teaches all as applied to claim 27, and in addition Tuschel teaches wherein the one or more detectors comprises a camera (paragraphs 0029, 0038).
As to claim 35, Tuschel in view of Levenson teaches all as applied to claim 27 except wherein the range of wavelengths to obtain the spectral data are in a visible near infrared (VNIR) range. However, examiner takes Official Notice that obtaining/detecting spectral data are in the visible near infrared (VNIR) range is well known.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide for obtaining/detecting spectral data in the visible near infrared (VNIR) range from biological sample/tissue in order to characterize said sample/tissue in said range.
As to claims 36, 47, Tuschel in view of Levenson teaches all as applied to claim 27, and in addition Tuschel teaches wherein the spectral data is hyperspectral data (abstract, paragraphs 0038, 0043, 0010-0011).
As to claim 42, Tuschel in view of Levenson teaches all as applied to claim 27. Tuschel is silent wherein the amyloidopathy or amyloidosis is indicative of Alzheimer's disease. However, Levenson, in the same field of endeavor, teaches sample imaging and classification comprising detection and characterization of amyloid (paragraphs 0161, 0165).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to detect and characterize a sample containing amyloid in order to provide proper treatment regimen to proper amyloid disease (paragraphs 0165, 0161, 0165).
Allowable Subject Matter
Claims 32-34, 38-41, 48, are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As to claim 32, the prior art of record, taken alone or in combination, fails to disclose or render obvious a method, wherein analyzing the spectral data comprises analyzing the spectral data over the range of wavelengths to determine whether the spectral data is indicative of a formation of amyloid aggregates indicative of at least one of amyloidopathy or amyloidosis or a predisposition to at least one of amyloidopathy or amyloidosis in the subject, in combination with the rest of the limitations of the claim. Claims 33-34 depend on claim 32.
As to claim 38, the prior art of record, taken alone or in combination, fails to disclose or render obvious a method comprising comparing the spectral data of the eye tissue to at least a first previous spectral data obtained from the eye tissue of the subject at an earlier point in time, wherein differences between the spectral data of the eye tissue and the first previous spectral data obtained from the eye tissue indicates the subject has one or more disorders resulting from at least one of amyloidopathy or amyloidosis or is predisposed for developing one or more disorders resulting from at least one of amyloidopathy or amyloidosis, in combination with the rest of the limitations of the claim.
As to claim 39, the prior art of record, taken alone or in combination, fails to disclose or render obvious a method comprising comparing the spectral data from the subject to a control spectral data and to a disorder reference spectral data to determine whether the spectral data comprises differences that are indicative of one or more disorders resulting from at least one of amyloidopathy or amyloidosis, in combination with the rest of the limitations of the claim.
As to claim 40, the prior art of record, taken alone or in combination, fails to disclose or render obvious a method, wherein the spectral data is obtained non-invasively and without administration of dyes for detection of amyloid aggregation, in combination with the rest of the limitations of the claim.
As to claim 41 , the prior art of record, taken alone or in combination, fails to disclose or render obvious a method, wherein the amyloidopathy or amyloidosis is indicative of cerebral amyloid angiopathy, familial amyloid polyneuropathy, Parkinson's disease, Huntington's disease, prolactinoma, or a transmissible spongiform encephalopathy, in combination with the rest of the limitations of the claim.
As to claim 48, the prior art of record, taken alone or in combination, fails to disclose or render obvious a method of claim 46, wherein the one or more disorders comprise cerebral amyloid angiopathy, familial amyloid polyneuropathy, Parkinson's disease, Huntington's disease,
prolactinoma, or a transmissible spongiform encephalopathy, in combination with the rest of the limitations of the claim.
Claims 43-45, are allowed over the prior art of record.
The following is an examiner’s statement of reasons for allowance:
As to claim 1, the prior art of record, taken alone or in combination, fails to disclose or render obvious a method, comprising: analyzing the spectral data over the range of wavelengths to determine whether the spectral data is indicative of a formation of amyloid aggregates., in combination with the rest of the limitations of the claim.
Claims 44-45 are allowed by the virtue of dependency on the allowed claim 43.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDULLAHI NUR whose telephone number is (571)270-1298. The examiner can normally be reached on M-F, 9am to 6pm.
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/ABDULLAHI NUR/Primary Examiner, Art Unit 2886
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