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 .
Election/Restrictions
Claims 11 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/26/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: the word “neurodeg” appears in the claim; it is assumed that the word was inadvertently truncated during the drafting of the claims. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 and 13-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) alkaline phosphatase. This judicial exception is not integrated into a practical application because the claims only disclose a product of nature, and provide no additional ingredients to suggest that the composition provides for more than the judicial exception.
The independent is drawn to a composition comprising alkaline phosphatase, wherein the composition is used as a treatment/prophylaxis for a neurodegenerative disease. That is, the claim can be broken into the composition, per se, and an intended use for the composition.
The only limitations drawn to the composition, per se, is the explicit claim towards alkaline phosphatase, wherein claim 5 further limits the types of alkaline phosphatase to those from intestinal, placental, or hepatic sources. Based upon the prior art, alkaline phosphatase, including those claimed in claim 5, can be naturally extracted from nearly every organism on the planet, wherein those claimed in claim 5 are routinely found in animals, like humans. See Lalles (Nutrition Reviews, 72, 82-94, 2014), page 82, “Abstract” section; Kiss (PGPub 2013/0251701), paragraph [0026]. As such, the explicitly claimed ingredient of the composition is considered a product of nature. When considering the analysis of these limitations with respect to 35 USC 101, the Applicant is directed to MPEP 2106, particularly the flow chart provided in section III. As such, both steps 1 and 2A can be answered “yes.” Step 2B asks if the claim recited additional elements, wherein the claim further defines an intended use for the claimed composition. Since this intended use does not affect the structure or compositional elements of the composition, per se, this limitation does not affect the product of nature. See MPEP 2106.04(d)(2). That is to say, the composition, per se, would appear the same regardless of the presence of any intended use limitations, wherein the intended use limitation does not affect any elements of the composition. Therefore, step 2B would be answered “no,” and the claim is not eligible under 35 USC 101.
Many of the dependent claims further classify the type of treatment/prophylaxis being performed, or define dosages, neither of which affect the composition, per se, which entirely comprises a product of nature. While it is noted that some dependent claims are drawn to recombinant forms of alkaline phosphatase, or synthetic alkaline phosphatases, these are assumed to possess the same amino acid sequence as those found in nature, and as such, can be defined as a product of nature. See MPEP 2106.04(c). This assumption is reasonable, since there are no sequences provided to suggest alkaline phosphatases with sequences that are not from nature.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10 and 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watcher, et al (WO 2018/175413). Watcher provides for a composition that comprises alkaline phosphatase. See page 1, line 11. Watcher indicates that the composition can be used in methods of treating neurological diseases, including multiple sclerosis. See page 41, line 24. Although Watcher does not explicitly teach the claimed physiological effects, Watcher teaches a patentably indistinct composition, wherein any effects following its administration would be inherent to the composition, per se. See MPEP 2112.
With respect to claim 1, Watcher teaches all of the compositional elements of the claimed composition. Watcher also suggests that the composition could be useful in a method of treating a neurological disease, which is consistent with the claimed “neurodegenerative disease.” Regardless, Watcher explicitly teaches the claimed composition, and any effects that composition provides to a subject following administration is inherent to the composition, per se. Since Watcher teaches the composition, per se, the claim is anticipated.
With respect to claims 2 and 13, as discussed above, Watcher explicitly teaches the compositional elements of the claimed composition. Since the claim limitations further narrow the subject-pool in a method of treating/prophylaxis, but do not change the compositional elements of the composition, Watcher continues to anticipate the composition, per se.
With respect to claim 3, Watcher explicitly teaches the compositional elements of the claimed composition. As such, all of the claimed physiological effects, following administration, would be inherent to the composition, per se.
With respect to claims 4 and 14, although the claim limitation does not affect the scope of what is in the claimed composition, Watcher describes the claimed dosage forms. See page 37, lines 5-37.
With respect to claims 5 and 15, Watcher teaches intestinal, placental, and liver alkaline phosphatase. See page 3, lines 10-14.
With respect to claims 6 and 16, Watcher teaches the claimed forms of administration. See page 20, lines 10-14.
With respect to claims 7, 8, 17 and 18, Watcher teaches recombinant and modified forms of alkaline phosphatase. See page 3, line 15.
With respect to claims 9 and 10, as discussed above, Watcher anticipates the claimed composition, per se. Even if Watcher does not explicitly teach the claimed method steps, these do not affect the scope of the composition. Since Watcher explicitly anticipates the claimed composition, these method steps and physiological affects would be inherent to the composition.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Brands, et al (PGPub 2017/0072027).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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