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 .
Claim Status
The claim set and Applicant’s remarks filed July 21, 2026 have been entered.
Claims 2, 4-12, 16-22 and 25-27 are canceled.
Thus, claims 1, 3, 13-15, 23-24, and 28-30 as amended are examined on the merits herein.
Withdrawn Objections and Rejections
With respect to the objections and/or rejections mailed in the non-final office action on April 21, 2026:
(I) The rejection of claims 4-8, 10 and 16 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in view of Applicant canceling these claims as discussed above.
(II) The rejection of claim 16 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph is withdrawn in view of Applicant canceling this claim as discussed above.
Response to Arguments
The rejection of claims 1, 3, 13-15, 23-24 and 28-30 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is maintained.
Applicant argues:
(A) It is not needed to have reduced the invention to practice prior to filing if the invention is otherwise disclosed in such a manner that one of ordinary skill in the art will be able to practice it without undue amount of experimentation, see Applicant’s remarks, pg. 6, first paragraph.
With respect to Applicant’s argument (A), the Examiner notes as written in the maintained enablement rejection below, the Examiner discussed the Treder reference which disclosed while sialic acid-based therapeutics are an evolving highly promising therapeutic platform that may one day provide promising outcomes and may potentially treat other neurodegenerative disorders and psychiatric disorders, other than treating Alzheimer’s disease which has been the predominately focused condition based on current research, sialic acid-based therapeutics relevance to human neurobiology and therapeutic efficacy remains uncertain.
Thus, the Examiner notes the potential role of sialic acid-based therapeutics in treating neurodegenerative and/or psychiatric disorders warrants particular attention that is disease specific, and in view of Treder the state of the art has not yet been investigated, particularly the disorders recited in instant claim 1.
(B) The specification need not disclose what is well-known to those skilled in the art and preferably omits that which is well-known to those skilled and already available to the public, see Applicant’s remarks, pg. 6, first paragraph.
With respect to Applicant’s argument (B), the Examiner reiterates their position above and further notes Treder also discloses therapeutic strategies targeting sialic acid-recognizing receptors may exhibit divergent outcomes in human systems compared to preclinical models; the Examiner reiterates the state of current research as disclosed by Treder has focused primarily on Alzheimer’s disease; Applicant has not tested other recited diseases or disorders recited in instant claim 1 other than Alzheimer’s disease; and finally, the state of the art nor the Applicant’s specification provide a single cause or mechanism of disease that links the disparate and distinct diseases or disorders as recited in instant claim 1 or provides any scientific rationale based on evidence why any disease or disorder as recited in instant claim 1, other than Alzheimer’s disease, can be effective treated with the polysialic acid compound of general formula (I) as recited in instant claim 1.
Thus, Applicant’s arguments (A)-(B) have been fully considered but are not found persuasive.
New Claim Rejections
The following is a modified rejection necessitated by Applicant's amendment, filed on July 21, 2026, where the limitations in pending claims 1, 3, 13-15, 23-24 and 28-30 as amended now have been changed.
Therefore, the 112 rejection from the previous Office Action, dated April 21, 2026, has been modified and is listed below.
35 USC § 112
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.
Claims 1, 3, 13-15, 23-24 and 28-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating Alzheimer's disease by administering a therapeutically effective amount of a polysialic acid according to general formula (1), wherein Neu5Ac is N-acetylneuraminic acid and n is 10, does not reasonably provide enablement for treating tauopathy, depression, Huntington's disease, amyotrophic lateral sclerosis, and stroke by administering a therapeutically effective amount of a polysialic acid according to general formula (1) as discussed above. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: The claimed invention is drawn to treating a neurological and neuropsychiatric disorder as recited in claim 1 by administering a therapeutically effective amount of the polysialic acid of general formula (1) as required in claim 1.
The Examiner notes that claim 1 recites the neurological and neuropsychiatric disorder is selected from Alzheimer’s disease, tauopathy, depression, Huntington’s disease, amyotrophic lateral sclerosis, and stroke.
Therefore, to be enabled for the full scope of treatment of the neurological and neuropsychiatric disorders recited in claim 1, one skilled in the art must reasonably be able to ascertain which agents are effective, obtain said agents, and successfully use said agents for treating said disorders.
The state of the prior art: The state of the art does not provide an expectation that administering the polysialic acid of general formula (1), where n is 10, may treat the scope of neurological and neuropsychiatric disorders recited in claim 1.
Attention is drawn to Treder et al. (Published 10 December 2025, pharmaceuticals, Vol. 17, Issue 12, pp. 1-23, PTO-892 mailed 04/21/2026); where Treder discloses a review of sialic acid in neurodegenerative and psychiatric disorders, see pg. 1, title.
Treder discloses sialic acid and polysialylation as diagnostic markers in psychiatric and neurodevelopmental disorders by stating the potential role of sialic acid in both the onset and progression of neurodegenerative diseases which warrants particular attention, as it may represent a key molecular link between dysregulated cellular processes and impaired neuronal function; and to date research on the multifaceted roles of sialic acid and polySia in neurodegenerative and psychiatric disorders has primarily focused on the most prevalent condition, Alzheimer’s disease, see pg. 5, 3. Sialic Acid and Polysialylation as Diagnostic Markers in Psychiatric and Neurodevelopmental Disorders, paragraph 1.
Treder discloses studies demonstrating the versatile applications of sialic acid in neurodegenerative disease therapeutics. However, these advances underscore that while current research has predominately focused on Alzheimer’s disease, sialic acid-based therapeutics could provide promising outcomes in the future to other neurodegenerative disorders and potentially to psychiatric conditions, see pg. 16, paragraph 2.
Treder discloses Huntington’s disease treatment is generally limited to tetrabenazine or deutetrabenazine for chorea management, see pg. 4, paragraph 1.
Additionally, Treder discloses despite growing evidence linking aberrant polysialylation with psychiatric disorders such as depression, few studies have investigated the therapeutic restoration of polysialylation or targeted modulation of polysialyltransferases in vivo, see pg. 18, paragraph 2.
Moreover, Treder discloses despite the remarkable progress achieved in understanding the multifaceted role of sialic acid and polysialylation in the pathophysiology and treatment of neurodegenerative and psychiatric disorders, several key challenges limit their translation from experimental to clinical conditions; and consequently, therapeutic strategies targeting sialic acid-recognizing receptors may exhibit divergent outcomes in human systems compared to preclinical models; and while preclinical findings are promising, their relevance to human neurobiology and therapeutic efficacy remains uncertain, which therefore underscores the need for advanced humanized models and rigorous translational frameworks before clinical evaluation can be initiated. See pg. 17, 5. Limitations, Challenges, and Future Perspectives of Sialic Acid-Based Strategies in Neurodegenerative and Psychiatric Disorders, paragraph 1 – pg. 18, paragraph 1.
Accordingly, in viewing the state of the art in its totality, based on the disclosure of Treder, the Examiner notes although Treder discloses sialic acid-based therapeutics are an evolving highly promising therapeutic platform that may one day provide promising outcomes and may potentially treat other neurodegenerative disorders and potentially psychiatric disorders, other than Alzheimer’s disease, sialic acid-based therapeutics relevance to human neurobiology and therapeutic efficacy remains uncertain, and therefore the potential role of sialic acid-based therapeutics in treating neurodegenerative and/or psychiatric disorders warrants particular attention that is disease specific as their use in human systems may exhibit divergent outcomes as explicitly disclosed by Treder above.
Thus, the actual use of the polysialic acid of general formula (1), wherein n is 10, in treating the neurological and/or neuropsychiatric disorders listed in claim 1 in a subject in need thereof is currently unclear.
The relative skill in the art: The relative skill of those in the art is high.
The predictability or lack thereof in the art: The Examiner notes the use of polysialic acid of general formula (1), where n is 10, in treating the neurological and/or neuropsychiatric disorders listed in claim 1 is currently unknown in view of the state of the art above.
Moreover, the disclosure of Treder as discussed above does not provide an expectation of treating the full scope of disorders listed in claim 1 with polysialic acid of general formula (1) as recited in claim 1. Consequently, at the time of the invention the field of therapies for treating the neurological and neuropsychiatric disorders recited in claim 1 by administering the polysialic acid of general formula (1) as recited in claim 1 was limited.
Thus, at the time of the invention the field of therapeutic use for treatment of the disorders recited above by administering the polysialic acid of general formula (1) of claim 1 was relatively underdeveloped and unpredictable.
The breadth of the claims: The scope of the claims recite the neurological and neuropsychiatric disorders listed within claim 1 are treated by administering the polysialic acid of general formula (1) as required in claim 1.
However, the Examiner particularly notes Treder, as discussed above, discloses the role of polysialic acid in the pathophysiological context has been predominately related to Alzheimer’s disease based on current research.
The amount of direction or guidance presented: The specification provides general guidance of polysialic acid of general formula (1) for use in treatment of a neurological and neuropsychiatric disorder, see pg. 1, paragraph [002], lines 1-4; where dysregulation of polysialic acid (polySia) has been associated with several neuropsychiatric, neurological/neurodegenerative disorders, including Alzheimer’s disease, see pg. 1, paragraph [003], lines 1-4.
In addition, the specification provides general guidance that polySia is found in distinct regions where neural plasticity, remolding of neural connections, or neurogenesis is ongoing, such as the hippocampus, subventricular zone (SVZ), thalamus, prefrontal cortex and amygdala, see pg. 1-2, paragraph [004], lines 5-8.
The presence or absence of working examples: The specification discloses one working example of the polysialic acid according to general formula (1) when n is 10 in the context of treating the disorders recited in instant claim 1.
Applicants provide example 11 where impaired recent object recognition memory in 5xFAD mice is normalized by DP10, see pg. 58, paragraph [00244].
Applicants tested whether DP10 or DP20 may improve cognitive function in the 5xFAD model of Alzheimer’s disease (AD), where 5xFAD mice treated with DP10 showed a preference for the least recently explored object as compared to the most recently explored object in the retrieval phase for DP 10 (Figure 14, upper panel) see pg. 58, paragraph [00245]; and although DP20 had a tendency to improve discrimination as compared to vehicle, mice treated with DP10 were significantly better in object discrimination as compared to both vehicle and DP20-treated groups, see pg. 58, paragraph [00245].
Additionally, the Examiner respectfully notes the specification does not provide evidence the recited compound of general formula (I) of claim 1 is effective in treating the full scope of the neurological and neuropsychiatric disorders listed in claim 1.
Note that lack of working examples is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art such as treatment of the neurological and neuropsychiatric disorders recited in claim 1, especially when considering the state of the art in view of the disclosure of Treder as discussed above. See MPEP 2164.
The quantity of experimentation required: Thus, in order to practice the invention of treating the neurological and neuropsychiatric disorders listed in claim 1, one of ordinary skill in the art would be required to undertake a novel and extensive research program to show that administration of the compound of general formula (I) of instant claim 1 could treat the neurological and neuropsychiatric disorders listed in claim 1, which in view of the state of the art as disclosed by Treder has predominately researched Alzheimer’s disease, and particularly in view of Treder disclosing therapeutic strategies targeting sialic acid-recognizing receptors may exhibit divergent outcomes in human systems and their relevance to human neurobiology and therapeutic efficacy remains uncertain.
Accordingly, because this research would need to be exhaustive, and because it would involve such a wide scope of disorders for which there is no single cause or mechanism of disease and involves treatment options of these diseases that are outside the scope of what is already known in the art, it would constitute an undue and unpredictable search and experimental burden.
Genentech, 108 F.3d at 1366, states that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Therefore, in view of the Wands factors, as discussed above, particularly the breadth of the claims, the nature of the invention, the state of the art and the lack of working examples, Applicants fail to provide information sufficient to practice the claimed invention of treating the neurological and neuropsychiatric disorders listed above by administering the polysialic acid of general formula (1) as required in instant claim 1.
Conclusion
No claims are allowed in this action.
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 JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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