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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submission filed on 01/06/2026, has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/07/2026, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures-Withdrawn
The request for Sequence Listing compliance, is withdrawn because the Applicants have submitted sequence listing within the Sequence Listing Requirement provided within 37 CFR 1.821 - 1.825, in the response filed on 01/06/2026.
Withdrawn Rejections
The rejection of claim 1 under 35 U.S.C. 101, is overcome by the Applicants’ amendment, and is hereby withdrawn. Specifically, Applicants amended claim 1 to introduce the limitation of administering a composition comprising one or more specific active ingredient(s).
Status of the Claims
Claims 1, 6-7, 10-18, 21-23 and 25 are pending.
Applicants’ arguments filed on 01/06/2026, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments filed on 01/06/2026, have been fully considered. Applicants have amended claims 1, 6, 10-13 and 21-23. Applicants have cancelled claims 9-8, 19-20 and 24. Applicants have newly added claim 25. Therefore, claims 1, 6-7, 10-18, 21-23 and 25 are subject of the Office action below.
Claim Rejections - 35 USC § 112-2nd paragraph
Maintained/New Grounds of Rejection Necessitated by Applicants’ Amendments
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.
The rejection of claims 1, 6-7, 10-18, 21-23, is maintained and newly added claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons of record set forth in the previous office action, of which said reasons are herein reiterated. Claims 6-7, 10-18, 21-23 and 25 depend from claim 1, and are therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for reasons set forth below.
As per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude (emphasis added). See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate (emphasis added). See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
Claim 1 recites the limitation “a threshold”, however, a person skilled in the art cannot reasonably determine the meets and bounds of this limitation in the claim. This is because, the scope of “a threshold”, is vague in that it is not clear from the specification as to what the “a threshold” is and how the step of the determination of the “a threshold”, is carried out. The specification does not provide a standard for ascertaining the requisite degree. Thus, one of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims. Appropriate correction is required.
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected.
Response to Applicants’ Arguments/Remarks
Applicants argue alleging that the rejection is improper on the grounds that Applicants have amended the claims to replacing the previously recited limitation “k is a predetermined threshold value”, with the limitation “a threshold” (see page 2 of Remarks).
Response
Applicants’ arguments have been fully considered but they are not found to be persuasive, because, the scope of “a threshold”, is vague in that it is not clear from the specification as to what the “a threshold” is and how the step of the determination of the “a threshold”, is carried out. The specification does not provide a standard for ascertaining the requisite degree. Thus, one of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 112-1st Paragraph
Maintained/New Grounds of Rejection Necessitated by Applicants’ Amendments
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of claims 1, 6-7, 10-18, 21-23, is maintained and newly added claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for the reasons of record set forth in the previous office action, of which said reasons are herein reiterated. Claims 6-7, 10-18, 21-23 and 25 depend from claim 1, and are therefore, also rejected aims 1 and 6-24 are rejected for reasons set forth below.
MPEP 2163 states:
“An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention….one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process”.
Amended claim 1 recites “determining that a ratio of the detected levels of the cathelicidin peptide LL-37 to the detected levels of the β-amyloid is less than a threshold”. Applicants cite ¶s 0047-0055 of the specification as allegedly providing support for the newly introduced limitation (see pages 2-3 of Remarks).
However:
¶ 0047 only relates to a method for upregulating cathelicidin gene expression in the brain of a subject, with a pharmaceutical composition comprising a mixture of actives selected from the group consisting of vitamin D3, phenylbutyrate, bexarotene, DHA, curcumin, resveratrol, and pharmaceutically acceptable salts thereof.
¶ 0048 only relates to a method for treating a human subject suffering from Alzheimer’s disease (AD), with a pharmaceutical composition which upregulates cathelicidin gene expression in the brain of the subject.
¶ 0049 only relates to a method for treating β-amyloid (Aβ) aggregation in a subject.
¶ 0050 only relates to a method for monitoring levels of cathelicidin peptide LL-37 (L) and β-amyloid (B) in tissues of a subject, and detecting when L/B<k, wherein k is a predetermined threshold value. It is not clear from the specification how the step of the predetermination of the threshold value (k), is carried out.
¶s 0051-0052 and 0055 only relate to a method for modulation in vivo Aβ fibril formation.
¶ 0053 only relates to a method for modulation microglia-mediated neuroinflammation.
¶ 0054 only relates to a method for inhibiting Aβ fibril formation.
A review of the specification (including ¶s 0047-0055, cited by the Applicants as allegedly providing support for the newly introduced limitation, see discussions above), fails to provide any support for “determining that a ratio of the detected levels of the cathelicidin peptide LL-37 to the detected levels of the β-amyloid is less than a threshold”. The phrase “determining that a ratio of the detected levels of the cathelicidin peptide LL-37 to the detected levels of the β-amyloid is less than a threshold”, is not recited in the specification.
Applicants have amended claim 1 to newly introduce a particular method step that is not described in the specification in such a way as to reasonably convey to one skilled in the art that the Applicants, at the time of the instant application, have possession of “determining that a ratio of the detected levels of the cathelicidin peptide LL-37 to the detected levels of the β-amyloid is less than a threshold”. Therefore, Applicants’ amendments filed on 01/06/2026, reciting the limitation of “determining that a ratio of the detected levels of the cathelicidin peptide LL-37 to the detected levels of the β-amyloid is less than a threshold”, has introduced new matter.
New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04(a) to § 608.04(c). Accordingly, the claim is considered to lack sufficient written description and are properly rejected under 35 U.S.C. 112(pre-AIA ), first paragraph.
Claim Rejections - 35 USC § 103
Maintained/New Grounds of Rejections Necessitated by Applicants’ Claim Amendments
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.
The rejection of claims 1, 6-7, 10-16, 21-22, is maintained and newly added claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Bevec of record (U.S. 20100210539) in view of:
1) Mily of record (Pulmonary Medicine, 2013);
2) Guo of record (J. Nutritional Biochemistry, 2013);
3) Ricobaraza of record (Hippocampus, 2012);
4) Durk of record (Neurobiology of Disease, 2014);
5) Casali of record (Neurobiology of Disease, 2015); and
6) Karuppagounder of record (Neurochemistry International, 2009),
for reasons of record set forth in the previous office action of which said reasons are herein reiterated.
By way of an introduction, Applicants disclose their invention as a method for inducing LL-37 peptide expression and reducing Aβ accumulation, as the underlying mechanism of action for the treatment of medical conditions such as AD (see, e.g., ¶s 0002, 0047-0049 of the specification). The specification provides a working example of administering a composition comprising phenylbutyrate, curcumin, bexarotene, vitamin D3, resveratrol, and DHA (see Table 2), to mice models of AD (see ¶ 00128 of the specification). Treated mice models of AD showed improvement in cognitive function compared to untreated controls (see ¶ 00129 of the specification).
Under the broadest reasonable interpretation (BRI), consistent with the specification, independent claim 1 is being interpreted as a method for treating an individual (e.g., AD patient, see claim 7), comprising:
i) monitoring levels of LL-37 peptide and Aβ in the individual;
ii) determining that a ratio of levels of the LL-37 peptide to the levels of Aβ is < a threshold1.
iii) administer to the individual, a composition comprising one or more compounds selected from the group consisting of phenylbutyrate, bexarotene, curcumin, resveratrol, retinal, cholecalciferol (vitamin D3) and a fatty acid or a pharmaceutically acceptable salt thereof.
Regarding claim 1, Bevec discloses LL-37 peptide as a therapeutic agent for the prophylaxis and/or treatment of neurodegenerative diseases (see ¶s 0001, 0137, reference claims 1 and 18), such as AD (see ¶ 0007). The peptide of the present invention was tested using the assays described in Examples 1-7, 9-17 for their effect as active therapeutic agents in the prophylaxis and/or treatment of neurodegenerative diseases and disorders (see ¶ 0137).
At the time of the instant invention, a person skilled in the art would have understood that Bevec contemplates treating a neurodegenerative disease (e.g., AD), with LL-37 peptide. Accordingly, one skilled in the art would have readily envisaged a method for treating AD with LL-37 peptide, in the Bevec disclosures.
Although Bevec is not explicit in teaching use of a composition that induces LL-37 peptide expression, the claimed invention would have been obvious over Bevec, because at the time of the instant invention, it was known in the art that an LL-37 peptide inducing agent can also be used for treating a neurodegenerative disease such as AD. For example:
1) Mily teaches a method for upregulating LL-37 peptide expression in humans, with a composition comprising phenylbutyrate with or without vitamin D3 (abstract and Figure 1). Combination of phenylbutyrate and vitamin D3 have been reported to synergistically induced LL-37 peptide expression (see abstract). Mily teaches monitoring levels of LL-37 peptide (see Figure 1).
2) Guo teaches a method of inducing CAMP gene expression with curcumin in model cell lines (see abstract, § 3.1 and Figure 1). CAMP gene expresses LL-37 peptide (see page 754). Therefore, one skilled in the art would have had a reasonable expectation that the administration of curcumin to an individual would induce CAMP gene (which expresses LL-37 peptide, see discussions above) expression in the individual. Since Guo teaches monitoring CAMP gene (see Figure 1), which expresses LL-37 peptide, Guo necessarily teaches monitoring levels of LL-37 peptide.
3) Ricobaraza teaches a method for reducing Aβ accumulation and improving cognition in mice models of AD with a composition comprising phenylbutyrate (see abstract). Ricobaraza teaches monitoring levels of Aβ (see Figure 4A).
4) Durk teaches a method for reducing Aβ accumulation and improving cognition in mice models of AD with a composition comprising vitamin D3 (see abstract, pages 7091-7100, Table 1 and Figures 1-8). Formation of Aβ plagues plays a key role in the pathogenesis of AD (see page 7091). Durk teaches monitoring levels of Aβ (see Figure 4B).
5) Casali teaches a pharmaceutical approach to treating a mouse model of AD with DHA (a fatty acid), in combination with bexarotene, in order to promote reduction in AD pathology and resultant amelioration of cognitive deficit. Please see abstract, pages 9173-9180 and Figures 1-5. Casali discloses that dual therapy provides better therapeutic efficacy, when compared to monotherapy with either DHA or bexarotene alone and suggested that targeted combinatorial agents may be beneficial over single agents alone in treating AD (see abstract). Although bexarotene has been shown to exhibit utility in mouse models of AD, the therapeutic use of bexarotene is accompanied by elevation of plasma triglycerides, as an undesired effect (see abstract and page 9173, 2nd ¶ on the right column). However, the bexarotene-induced hypertriglyceridemia was abrogated by DHA. Please see abstract, page 9176 and Figure 1. Similar to Ricobaraza (see discussions above), Casali discloses that AD is characterized by cognitive decline and memory loss, which accompany the impaired clearance of soluble forms of Aβ peptides, resulting in their accumulation and formation of Aβ plagues (see page 9173, 1st ¶ on the left column).
6) Karuppagounder teaches a pharmaceutical approach to treating a mouse model of AD with resveratrol, in order to reduce Aβ plague pathology (see title of the article, abstract, pages 111-117 and Figures 1-6). Similar to Ricobaraza and Casali (see discussions above), Karuppagounder discloses that formation of Aβ plagues plays a key role in the pathogenesis of AD (see page 111).
Accordingly, at the time of the instant invention, a person skilled in the art would have envisaged a method of treating an individual (e.g., an AD patient), comprising:
i) monitoring levels of LL-37 peptide and Aβ; and
ii) administering to the AD patient, a composition comprising one or more compounds (e.g., phenylbutyrate, bexarotene, curcumin, resveratrol, vitamin D3 and DHA),
in the disclosures of Bevec, Mily, Guo, Ricobaraza, Durk, Casali and Karuppagounder.
One skilled in the art would have had a reasonable expectation that the administration of the composition would induce LL-37 peptide expression, reduce Aβ accumulation and improve cognition in the AD patient.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
The requirement of determining a ratio LL-37 peptide to Aβ at < a threshold (e.g., <1, claim 6), is a result effective variable that would have been routinely determined and optimized in the pharmaceutical art. Factors determining L and B include, but not limited to, age, sex, body weight of the individual and severity of the condition or disease being treated in the individual.
Furthermore, MPEP § 2144.05(II)(B), states that “after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.”
Therefore, claims 1 and 6 are obvious over Bevec, Mily, Guo, Ricobaraza, Durk, Casali and Karuppagounder.
Regarding claims 7 and 15-16, the cited references combine to teach AD and Aβ accumulation (see discussions above).
Regarding claims 10-13, 21-22 and 25, the cited references combine to teach phenylbutyrate, bexarotene, curcumin, resveratrol, vitamin D3 and DHA (see discussions above).
Regarding claim 14, Mily teaches vitamin D3 in Vigantol oil (see “Methods” section on page 2).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
The rejection of claims 1,17-18 and 23 under 35 U.S.C. 103 as being unpatentable over Bevec in view of Mily, Guo, Ricobaraza, Durk, Casali and Karuppagounder, as applied to claim 1 above and further in view of Rossi of record (Neurochem. Res., 2008), is maintained for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
The limitations of claim 1 as well as the corresponding teachings of Bevec, Mily, Guo, Ricobaraza, Durk, Casali and Karuppagounder, are described above and are hereby incorporated into the instant rejections.
The invention of claims 17-18 and 23 are similar to claim 1, however, claims 17-18 and 23 differ slightly from claim 1 in that the claims further require monitoring a cytokine in microglia tissues of the individual.
Bevec, Mily, Guo, Ricobaraza, Durk, Casali and Karuppagounder differ from claims 17-18 and 23 only insofar as the cited references do not combine to explicitly disclose the limitations of claims 17-18 and 23.
However, the claimed inventions would have been obvious over Bevec, Mily, Guo, Ricobaraza, Durk, Casali and Karuppagounder, because at the time of the instant invention, it was known in the art that a cytokine is activated in microglia during inflammation and a cytokine level can reduced by antioxidants such as curcumin.
For example, Rossi (see page 2391), states:
“Another phenomenon strictly linked to aging and to neurodegeneration is inflammation. This process is related to ROS production, which act as signals to activate genes like iNOS, interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α) and nuclear factor kappa B (NFkB). Inflammation is a common feature of the elderly brain, involving the activation of the microglia and astrocytes, and oxidative stress–mediated neuroinflammation is reported in neurodegenerative diseases like Parkinson’s and Alzheimer’s [10, 11].” Emphasis added.
The positive effect of polyphenols such as curcumin (see Figure 1), on neurodegeneration is mediated by their anti-inflammatory role (see page 2393). Studies in animal model of AD treated with curcumin, revealed a decrease in oxidative stress markers and reduce Aβ plague pathology (see page 2396 and Table 2).
Accordingly, one skilled in the art would have had a reasonable expectation that the administration of a composition comprising curcumin to an individual (e.g., AD patient), would induce LL-37 peptide expression, reduce Aβ accumulation, decrease in oxidative stress markers and improve cognition in the AD patient.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Response to Applicants’ Arguments/Remarks
Applicants raised several arguments (see pages 3-6 of Remarks), alleging that the claimed invention is non-obvious over the cited prior art on the grounds that:
1) none of the cited references, alone or in combination have an appreciation of the LL-37 peptide and Aβ in the treatment of neurological disorders (see pages 3-5 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive, because the cited references combine to disclose:
i) LL-37 peptide as a therapeutic agent for the prophylaxis and/or treatment of neurodegenerative diseases (see discussions above).
ii) use of a composition comprising one or more compounds (e.g., phenylbutyrate, bexarotene, curcumin, resveratrol, vitamin D3 and DHA), to induce LL-37 peptide expression, reduce Aβ accumulation and improve cognition in the AD patient (see discussions above).
Accordingly, it would been obvious to a person skilled in the art that the cited references, alone or in combination have an appreciation of the LL-37 peptide and Aβ in the treatment of neurological disorders (e.g., AD).
2) none of the cited references assessed levels of LL-37 peptide and Aβ (see page 3 of Remarks).
Response:
The cited references combine to disclose monitoring levels of LL-37 peptide and Aβ (see discussions above).
3) none of the cited references assessed levels of interactions between LL-37 peptide and Aβ (see pages 3-4 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive, because the limitation of “levels of interaction between LL-37 peptide and Aβ”, is not recited in the instant claims.
4) Lee is the only reference that discloses an interplay between LL-37 peptide and AD, however, Lee allegedly teaches away from claim 1 because Lee concludes that data indicate that LL-37 expression may play a role in neurological disease (see page 4 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive, because Bevec discloses LL-37 peptide as a therapeutic agent for the prophylaxis and/or treatment of neurodegenerative diseases (e.g., AD, see discussions above).
5) the Examiner's conclusion of obviousness is based upon improper hindsight reasoning (see page 5 of Remarks).
Response:
Regarding the Applicants’ allegation that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was filed, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case:
The information regarding LL-37 peptide as a therapeutic agent for the prophylaxis and/or treatment of neurodegenerative diseases (e.g., AD), is gleaned from Bevec, who discloses LL-37 peptide as a therapeutic agent for the prophylaxis and/or treatment of neurodegenerative diseases (see discussions above).
The information regarding one or more compound that can induce LL-37 peptide expression, reduce Aβ accumulation and improve cognition in the AD patient, is gleaned from combination of Mily, Guo, Ricobaraza, Durk, Casali and Karuppagounder, who combined to disclose one or more compounds (e.g., phenylbutyrate, bexarotene, curcumin, resveratrol, vitamin D3 and DHA), that can induce LL-37 peptide expression, reduce Aβ accumulation and improve cognition in the AD patient (see discussions above).
It is therefore reasonable to conclude that the strength of correlation between one or more compounds (e.g., phenylbutyrate, bexarotene, curcumin, resveratrol, vitamin D3 and DHA), that can induce LL-37 peptide expression, reduce Aβ accumulation and improve cognition in the AD patient, gives rise to reasonable expectation of success.
For the reasons made of record in the previous Office action, the rejections are maintained.
Conclusion
No claim is allowable.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
1 the scope of “a threshold”, is not defined by the claims or the specification.