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 .
Response to Amendments
Amendments filed July 15, 2026 are acknowledged.
Any rejections not explicitly maintained are withdrawn.
Election/Restriction
Restriction mailed December 23, 2025 is withdrawn. All claims are rejoined
Status of Claims
5. Claims 1, 3, 7, 11, 15, 19, 21, 26-27, 32-34, 36, 38, 41, 43, 45-46, 49, and 52 are pending and under consideration.
Claim Rejections - 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.
6. Claims 45, 49 and 52 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 the treatment of conditions of the claims, does not reasonably provide enablement for the prophylactic treatment of said conditions. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
In this regard, the application disclosure and claims have been compared per the factors indicated in the decision In re Wands, 8 USPQ2d 1400 (Fed. Cir., 1988) as to undue experimentation. The factors include:
1) the nature of the invention;
2) the breadth of the claims;
3) the predictability or unpredictability of the art;
4) the amount of direction or guidance presented;
5) the presence or absence of working examples;
6) the quantity of experimentation necessary;
7) the state of the prior art; and,
8) the relative skill of those skilled in the art.
The relevant factors are addressed below on the basis of comparison of the disclosure, the claims and the state of the prior art in the assessment of undue experimentation.
For the purposes of consideration under 35 U.S.C. 112(a), the instant rejection focuses on the particular condition of Alzheimer’s disease. However, the reasons stated here concerning the burden of enabling the prevention of Alzheimer’s disease apply also to the myriad of other conditions circumscribed by the language encompassed by the present claims.
In particular, one skilled in the art could not practice the presently claimed subject matter of preventing Alzheimer’s disease by administering the claimed composition without undue experimentation because the artisan would not accept on its face that prevention of Alzheimer’s disease could actually be achieved given the state of the art at the time of the invention. Based upon the state of the art, as discussed below, and the evidence presented by Applicant, the artisan would have only accepted that the condition could be treated with the instantly claimed composition as instantly claimed.
As set forth in In re Marzocchi et al., 169 USPQ 367 (CCPA 1971):
“[A] [s]pecification disclosure which contains the teachings of manner and process of making and using the invention in terms corresponding to the scope to those used in describing and defining subject matter sought to be patented must be taken as in compliance with the enabling requirement of first paragraph of 35 U.S.C. 112, unless there is reason to doubt the objective truth of statements contained therein which must be relied on for enabling support; assuming that sufficient reasons for such doubt exists, a rejection for failure to teach how to make and/or use will be proper on that basis, such a rejection can be overcome by suitable proofs indicating that teaching contained in the specification is truly enabling.” (emphasis added)
Treatment is defined as follows to include prophylactic treatment:
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The present claims circumscribe the use of the presently claimed composition for the prevention of Alzheimer’s disease. That is, in order to be enabled to practice the present invention, the skilled artisan would have to accept that by using the presently claimed compound that Alzheimer’s disease would actually be prevented from developing or worsening or that the onset of Alzheimer’s disease could be prevented. In other words, the skilled artisan would have understood the term “prevention” to mean that the claimed composition was capable of impeding the development of such a condition such that it would be “prevented”, i.e., reasonably expected not to occur, in such a population treated via the instantly claimed compounds. Because such preventive success is not reasonably possible with most diseases or disorders, especially a condition as complex and poorly understood as Alzheimer’s disease, the specification, which lacks any direction or guidance as to how prevention of Alzheimer’s disease could actually be achieved, is viewed as lacking an enabling disclosure of the entire scope of the claimed invention.
Regarding the prevention of Alzheimer’s disease, the objective truth of the statement that Alzheimer’s disease may be prevented or can be delayed from developing is doubted because the disease is particularly elusive and manifests itself in a variety of different ways in different subjects such that the diagnostician cannot be sure that the disease is truly the cause of the signs and symptoms of disorder exhibited by the patient. A diagnosis of Alzheimer’s disease is tentative, at best, until confirmation of the diagnosis can be confirmed by the presence of amyloid deposits in the brain at autopsy (see Cecil’s Textbook of Medicine, “Differential Diagnosis”, page 2043 at column 1).
Such difficulties in diagnosis are recognized in the art. Applicant’s attention is drawn to Cecil’s Textbook of Medicine, which states, “In a patient with clinical findings suggesting Alzheimer’s disease, other causes of dementia should be excluded by history, examination, and the laboratory studies described above. CSF evaluation for amyloid protein and tau protein can increase the likelihood of a diagnosis of Alzheimer’s disease, but they are not sufficiently specific to be of routine value in screening or early diagnosis of Alzheimer’s disease…Presence of the apoE4 allele makes it very likely that the patient’s dementia is produced by Alzheimer’s disease. ApoE testing does not have predictive value for asymptomatic individuals.” (see Cecil’s Textbook of Medicine, “Diagnosis”, column 2 at page 2044)
In this regard, it is also noted that the art acknowledges only certain criteria for definitive diagnosis of Alzheimer's disease, see in particular Gauthier et al., (Can. Med. Assoc. J, Oct 15, 1997, 157(8): 1047-52), Greicius et al. (J Neurol. Neurosurg. Psychiatry, 2002 Jun; 72(6):691-700) and Gasparini et al. (FASEB J., 12, Jan. 1998, pp. 17-34). Post mortem analysis of brain tissue for the characteristics of amyloid plaques is considered necessary for a definitive diagnosis. This is because the art has come to recognize its presence in essentially all cases. However, to achieve diagnostic status took years of evaluative procedures, both pre- and post-mortem, confirming that every case had a degree of this pathology. Even so, diagnostic application is often problematic given variable peptide expression patterns among clinically similar and dissimilar diseases states (see Greicius et al.).
Given that there a only a few factors that are recognized to have moderate, if any, predictive value in determining the likelihood that patients develop such a disease or to even determine whether patients actually have such a disease, since many of the early signs of Alzheimer's disease are common complaints of aging or result from other neurological conditions, such as depression, (see Cecil's Textbook of Medicine, “Evaluation of Dementia”, column 1, page 2042), one of ordinary skill in the art would not accept on its face Applicant's statement that the onset of Alzheimer’s disease could be delayed and/or prevented using the presently claimed composition. In fact, such complexity of diagnosis precludes a common, art-accepted protocol for preventing or delaying the onset of Alzheimer’s disease in any patient, given that the circumstances or risk factors are unique to that individual and must be considered on a case-by-case basis when determining the most effective approach to delaying or preventing Alzheimer’s disease.
In other words, not only is the population in need of such treatment not particularly well defined in the art because of the difficulties associated with making an accurate diagnosis, but the disease is also sufficiently complicated and poorly understood such that the idea that any active agent (including that presently claimed) would be capable of delaying or preventing the onset of such a condition via the use of the presently claimed composition would not have been reasonably expected by the skilled artisan. The artisan would have required sufficient direction as to how the administration of the presently claimed active agents could actually determine the population of patients in need of prevention and how the presently claimed composition could actually delay or prevent Alzheimer's disease such that the artisan would have been imbued with at least a reasonable expectation of success. Such success would not have been reasonably expected given that the concept of a single agent, or even a combination of agents, that is effective against the development of Alzheimer's disease would have been unique and, thus, met with a great deal of skepticism.
It is in this regard that Applicant is directed to the MPEP at §2164.08. All questions of enablement are evaluated against the claimed subject matter. Concerning the breadth of a claim relevant to enablement, the only relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. The determination of the propriety of a rejection based upon the scope of a claim relative to the scope of enablement involved the determination of how broad the claim is with respect to the disclosure and the determination of whether one skilled in the art is enabled to use the entire scope of the claimed invention without undue experimentation.
Also, while a lack of a working embodiment cannot be the sole factor in determining enablement, the absence of substantial evidence commensurate in scope with the presently claimed subject matter, in light of the unpredictable nature of the art and the direction that Applicant has presented, provides additional weight to the present conclusion of insufficient enablement in consideration of the Wands factors as a whole. The instant specification conspicuously lacks any disclosure or teaching of manner and process of using the presently claimed composition for achieving the objective of delaying the onset of or preventing Alzheimer’s disease itself. Nowhere does the specification disclose the manner or procedure of using the presently claimed composition for preventing Alzheimer’s disease such that the skilled artisan would have been imbued with at least a reasonable expectation of success in determining the patient population in need of prevention of Alzheimer’s disease without the burden of an undue level of experimentation.
The basis for the present rejection is not simply that experimentation would be required, since it is clear from the state of the pharmaceutical and chemical arts that experimentation in this particular art is not at all uncommon, but that the level of experimentation required in order to practice this aspect of the invention in the absence of any enabling direction by Applicant would be undue. Please reference In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976), which states, “The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue.” (emphasis added)
In view of the discussion of each of the preceding seven factors, the level of skill in the art is high and is at least that of a medical doctor with several years of experience in the art.
As the cited art and discussion of the above factors establish, practicing the claimed method in the manner disclosed by Applicant would not imbue the skilled artisan with a reasonable expectation that the objective of preventing the claimed disorder in a subject using the claimed composition could be achieved. In order to actually achieve such a result, it is clear from the discussion above that the skilled artisan could not rely upon Applicant’s disclosure as required by 35 U.S.C. 112(a), and would have no alternative recourse but the impermissible burden of undue experimentation in order to practice the full scope of the presently claimed invention.
Conclusion
7. Claims 1, 3, 7, 11, 15, 19, 21, 26-27, 32-34, 36, 38, 41, 43, and 46 are allowed..
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha Shterengarts whose telephone number is (571)270-5316. The examiner can normally be reached on Monday thru Thursday 9-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Adam Milligan can be reached on 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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9. THIS ACTION IS MADE FINAL. 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 extension fee 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.
/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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