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
Applicant’s election of AAD23 as the muscarinic M2 blocking compound and Alzheimer’s disease as the condition characterized by progressive memory decline, in the reply filed on 4/10/2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant has not pointed to any errors in the Examiner's Requirement for Restriction/Election of Species. The requirement is still deemed proper and is therefore made FINAL.
In the reply filed on 4/10/2026, applicant asserts that claims 1-8, 10-15, and 17-20 encompass the elected species. However, claim 2 is also drawn to a non-elected species (dementia) and is being withdrawn from consideration.
In the claims as filed on 4/10/2026, applicant has amended no claims; cancelled no claims; and added no new claims. Claims 2, 9, and 16 are withdrawn based on the species election. Claims 1-20 are currently pending, and claims 1, 3-8, 10-15, and 17-20 are presently under examination.
Priority
The instant application is a continuation of U.S. Application No. 15/912,370, filed March 5, 2018, which claims the benefit of U.S. Provisional Application No. 62/467,024, filed March 3, 2017.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 2/23/2024 is in compliance with the provisions of 37 CFR 1.97. All references have been considered except where marked with a strikethrough. A signed copy of Form 1449 is included with this Office Action. Note: the documents marked with a strikethrough have neither been found or placed in the instant application file nor found or placed in the parent application file (Application No. 15/912,370).
Specification
Acknowledgement is made of the drawings received September 25, 2023.
The drawings are objected to because:
In FIG. 1, the lanes of the Western blot are illegible and it is difficult to determine the wild type or knockout allele status. As recited in 37 CFR 1.84:
(l) Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informality: for consistency, the claim should be written in the singular format. The examiner suggests that claim 1 be rewritten to read, “A method for delaying or preventing onset of progressive memory decline in a patient in need of such treatment…” (emphasis added) so as to be consistent with proper Markush practice. Appropriate action is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1, 3-4, 7-8, 11, 14-15, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
With regards to claims 1, 3-4, 7, 11, 14, and 18, the term “at risk” is vague and indefinite because it is not clear what Applicant is claiming. Applicant does not formally define “at risk” or associated risk factors in the Specification. Rather, Applicant provides and contemplates (page 9, [33]) an open-ended list that “include but not limited to the following: (1) Memory complaint with the Mini Mental State Examination (MMSE) or other memory test indicating mild cognitive impairment (MCI); (2) ApoE allele assay revealing as ɛ4 allele carrier; (3) Age is older than 65; (4) Female; (5) Having a family member or relatives suffering from AD (even though no known mutations are identified); (6) Medical history of having other related disease such as cardiovascular diseases, stroke, diabetes, brain trauma, etc (7) Functional MRI (fMRI) revealing reduced cerebral blood flow and brain metabolism. (8) Others, such as GRK5 deficiency” (emphasis added). Is this the entire scope of the risk factors for progressive memory decline, or are there others? Applicant only provides non-limiting examples.
With regards to claims 1, 8, and 15, the phrase “experiencing a condition characterized by progressive memory decline” is vague and indefinite because it is not clear what Applicant is claiming. Applicant does not define in the Specification what is “experiencing a condition characterized by memory decline” and is therefore open-ended.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5 and 12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 is directed to a method, wherein “the muscarinic M2 receptor blocking compound is initially administered prior to patient’s onset of memory decline”. Claim 5 depends on claim 4, which in turn depends on claim 1. Claim 1 already establishes that the muscarinic M2 receptor blocking compound is administered “prior to the onset of the condition”, wherein the condition is “a condition characterized by progressive memory decline”.
Claim 12 is directed to a method, wherein “the first administration of the muscarinic M2 receptor blocking compound is prior to subject’s onset of memory decline”. Claim 12 depends on claim 11, which in turn depends on claim 7. Claim 7 already establishes that the muscarinic M2 receptor blocking compound is administered “prior to the onset of progressive memory decline”. The “first administration” of claim 12 is already understood by claim 7, which requires that the administration happens before the onset of the progressive memory decline.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)
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.
Written Description – At Risk/Risk Factors
Claims 1, 3-4, 7, 11, 14, and 18 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a Written Description rejection.
A lack of adequate written description issue 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. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
The instant specification does not adequately describe “a patient that is at risk of developing a condition characterized by progressive memory decline”. Applicant provides (page 9, [33]) an open-ended list of risk factors that “include but not limited to the following: (1) Memory complaint with the Mini Mental State Examination (MMSE) or other memory test indicating mild cognitive impairment (MCI); (2) ApoE allele assay revealing as ɛ4 allele carrier; (3) Age is older than 65; (4) Female; (5) Having a family member or relatives suffering from AD (even though no known mutations are identified); (6) Medical history of having other related disease such as cardiovascular diseases, stroke, diabetes, brain trauma, etc (7) Functional MRI (fMRI) revealing reduced cerebral blood flow and brain metabolism. (8) Others, such as GRK5 deficiency” (emphasis added). Applicant contemplates many risk factors, but only demonstrates possession, wherein the risk factor is GRK5 deficiency, in the GAP mouse model (see Example 1, pages 11-13, [041-045]; and Example 4, page 17, [66]).
Furthermore, there is no single “one-size-fits-all” standard list of risk factors for progressive memory decline because progressive memory decline is shaped by a complex interplay of genetics, environment, lifestyle, and social factors. As such, the “include[ing] but not limited to” language of the Specification can include a multitude of patient populations. The lack of an agreed-upon standard list of risk factors, or an “at risk” patient population, is demonstrated by the following references:
The Alzheimer’s Association (“Risk Factors for Cognitive Decline: United States”) reports: midlife hypertension, physical inactivity, midlife obesity, diabetes, smoking, and poor sleep;
The CDC reports (Omura et al.): hypertension, not enough aerobic physical activity, obesity, diabetes, cigarette smoking, excessive alcohol use, depression, and hearing loss;
Meanwhile, the NIH Institute on Aging reports (“Understanding Risk and Protective Factors for Dementia”) new genetic and environmental risk factors including: vision impairment, exposure to air pollution, living in lower income neighborhoods with less green space, sedentary behavior, barriers to health care, etc.
As such, Applicant lacks Written Description for “a patient that is at risk of developing a condition characterized by progressive memory decline”. Claims 1, 3-4, 7, 11, 14, and 18 are therefore rejected under 35 USC § 112(a).
Written Description – Muscarinic M2 Receptor Blocking Compound
Claims 1, 3-8, 10-15, and 17-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a Written Description rejection.
In the present application, the specification must provide sufficient distinctive or unique identifying characteristics for a method for delaying or preventing onset of progressive memory decline
in patients in need of such treatment, wherein said method comprises: identifying a patient that is at risk of developing a condition characterized by progressive memory decline; and administering to the patient, prior to onset of the condition, a therapeutically effective amount of a muscarinic M2 receptor blocking compound; wherein the patient has not been diagnosed as currently experiencing a condition characterized by progressive memory decline at the time of administration of the muscarinic M2 receptor blocking compound. Under the standards of 35 U.S.C. §112(a), though the invention need not be described ipsis verbis, i.e., literally, for purposes of the written description requirement, but the skilled person needs to understand, based on the disclosure in the specification as filed and the knowledge imputed to the skilled artisan at the time the specification was filed, that the inventor had possession of the claimed subject matter.
As the Federal Circuit has stated: The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872, F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989).
The factors considered in the Written Description requirement are:
(1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and (5) the method of making the claimed invention.
(1) Level of skill and knowledge in the art:
The level of skill to practice the art of the instantly claimed method is high and requires a variety of skills usually found in institutions and companies that employ highly trained and skilled scientists to carry out these tasks.
(2) Partial structure: (3) Physical and/or chemical properties: and (4) Functional characteristics:
The claims of the instant invention are directed to a method for delaying or preventing onset of progressive memory decline in patients in need of such treatment, wherein said method comprises: identifying a patient that is at risk of developing a condition characterized by progressive memory decline; and administering to the patient, prior to onset of the condition, a therapeutically effective amount of a muscarinic M2 receptor blocking compound; wherein the patient has not been diagnosed as currently experiencing a condition characterized by progressive memory decline at the time of administration of the muscarinic M2 receptor blocking compound.
The specification demonstrates behavioral testing using GAP mice models that were dosed orally with 2-3 mg/kg of AAD23. Note: GAP mice are a Swedish mutant Aβ precursor mouse model with GRK5 deficiency. Based on the data, applicant concluded (page 17, [66]):
…no significant differences were identified between any groups for open field, balance beam, string agility and elevated plus maze tests, indicating these animals were not impaired for their sensorimotor function and anxiogenic tendencies. However, for the two tasks that measure mnemonic performance (Y maze and MWM), the untreated GAP mice were known to be impaired at 12-month for Y maze spontaneous alternation and MWM platform probing, according to our previous data. With 6 months of treatment of AAD23, they performed significantly better than those untreated GAP mice, and their levels of performance were as good as the WT mice (FIGS. 3, 4, and 5). These results suggest that 6 months of AAD23 treatment mice significantly prevented the memory decline in the GAP mice. (emphasis added)
It appears that the mouse model does not demonstrate identifying a subject at risk of developing a condition characterized by progressive memory decline by administering any muscarinic M2 receptor blocking compound. The as-filed specification does not demonstrate that all muscarinic M2 blocking compounds would have had the same therapeutic benefit of preventing memory decline.
The state of the prior art discloses several muscarinic M2 blocking compound (page 10, [35]); however, such compounds differ in chemical structure. Given the fact that there is a myriad of compounds that fall within applicant’s definition (i.e., “a muscarinic M2 receptor blocking compound”), it is premature to concluded that any muscarinic M2 receptor blocking compound would have had the same therapeutic effect. In addition, the state of the prior art does not provide any guidance or indication that all of the compounds encompassed by “muscarinic M2 receptor blocking compound” would have been effective in the prevention of progressive memory decline.
Thus, the specification fails to describe the structure and activity for the recited muscarinic M2 receptor blocking compound for delaying or preventing onset of progressive memory decline in patients at risk of developing a condition characterized by progressive memory decline.
Under the standards of 35 U.S.C. §112(a), though the invention need not be described ipsis verbis, i.e., literally, for purposes of the written description requirement, but the skilled person needs to understand, based on the disclosure in the specification as filed and the knowledge imputed to the skilled artisan at the time the specification was filed, that the inventor had possession of the claimed subject matter.
Therefore, applicants have failed to provide guidance or data or evidence as to how the skilled artisan would be able to extrapolate from the disclosure to make and possibly use the claimed invention. “A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F 3d at 923; Eli Lilly, 119 at 1568. Instead, the “disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.”
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521,222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.").
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claimed subject matter and does not reasonably convey to one skilled in the relevant art that the inventors had possession of the entire scope of the claimed invention.
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 3-8, 10-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schrattenholz et al. (WO 2006/008118 A1, published January 26, 2006, cited on IDS filed 2/23/2024)(hereinafter, ‘Schrattenholz’) in view of Eglen et al. (“Selective Muscarinic Receptor Agonists and Antagonists”, published February, 1996, cited on IDS filed 2/23/2024)(hereinafter, ‘Eglen’).
Schrattenholz teaches to the cytoprotective activity of mixed muscarinic inhibition/PARP modulation and/or SIR2 modulation as medicaments for the prevention and/or treatment of neurological diseases (page 2, para 1). Compounds include compounds of reference Formula I and related compounds, such as BIBN 99 and DIBD (page 12, para. 5; claim 11). The compounds of formula I are used for the prevention or treatment of neurodegenerative or neuroinflammatory conditions (claim 3). Schrattenholz teaches the treatment prevention or treatment of neurodegenerative or neuroinflammatory conditions with dementia, Parkinson, Alzheimer, stroke, schizophrenia or epilepsy (claim 40). The medicament may be administered according to any known means, wherein oral and intravenous administration is particularly preferred (page 14, para 2). The dose of the active ingredient depends on the type and the variety of disease and usually is in the range from 1 to 2000 mg/day (page 14. para. 2).
Eglen teaches that BIBN 99 is a novel muscarinic M2 receptor antagonist (page 63, col. 1, para. 2).
Schrattenholz does not explicitly teach preventing onset of Alzheimer’s disease (instant claim 1), wherein administering to a patient, prior to onset of the condition, a therapeutically effective amount of a muscarinic M2 blocking compound and administering a therapeutically effective amount of muscarinic M2 blocking compound to the subject prior to onset of Alzheimer’s disease (instant claims 1 and 7), wherein the patient has not been diagnosed as currently experiencing a condition characterized by progressive memory decline (claim 7), delaying onset of Alzheimer’s disease in the subject by repeated administration of the therapeutically effective amount of a muscarinic M2 receptor blocking compound (instant claims 7 and 14), wherein the patient has not been diagnosed as currently experiencing Alzheimer’s disease at the time of administration of AAD23 (instant claims 1 and 8).
A person of ordinary skill in the art before the effective filing date would have found it prima facie obvious to develop a method of preventing onset of Alzheimer’s disease to a patient who may develop a condition characterized by Alzheimer’s disease by administering a therapeutically effective amount of AAD23 (muscarinic M2 inhibitor) because Schrattenholz taught a method of preventing Alzheimer’s disease comprising administering a therapeutically effective amount of BIBN 99 (e.g., muscarinic M2 inhibitor). Motivation to replace the BIBN 99 with AAD23 would have resulted from the fact that Schrattenholz taught a method of preventing Alzheimer’s disease by administration of therapeutically effective amount of muscarinic M2 inhibitor and Eglen taught that BIBN 99 is muscarinic 2 receptor antagonist. Further, motivation would have resulted from the fact Schrattenholz demonstrates a muscarinic M2 receptor antagonist mechanism of action useful for the prevention of Alzheimer’s disease. The examiner is interpreting preventing the disease as not being present or has been diagnosed in a patient. The skilled artisan would have understood that the subjects of Schrattenholz are identifying has subjects who may develop Alzheimer’s disease since it discloses a method of prevention. Therefore, the methods of Schrattenholz encompass patients who may develop Alzheimer’s disease due to have being identified for the prevention of Alzheimer’s disease. Thus, the skilled artisan would have found motivation and instruction to administer AAD23 to a patient in need of Alzheimer’s disease prevention from the teachings of Schrattenholz. Furthermore, Schrattenholz taught a method of preventing Alzheimer’s disease using the biological pathways of inhibiting muscarinic pathway.
In regards to the limitation wherein administering to a patient, prior to onset of the condition, a therapeutically effective amount of muscarinic M2 blocking compound and administering a therapeutically effective amount of muscarinic M2 blocking compound to the subject prior to onset of Alzheimer’s disease as recited in claim 1: The examiner is interpreting the claim limitation as a patient that is beginning to show early signs or symptoms of Alzheimer’s disease. Schrattenholz taught a method of preventing and treating Alzheimer’s disease comprising administering a therapeutically effective amount of BIBN 99 (e.g., muscarinic M2 inhibitor). The skilled artisan would have understood that the method for preventing onset of Alzheimer’s disease is identifying a patient who may develop Alzheimer’s disease or could have been showing signs of the condition as taught by Schrattenholz. Furthermore, Schrattenholz taught a method of preventing and treating Alzheimer’s disease by administering a dose of in the range from 1 to 2000 mg/day. Thus, the skilled artisan would have understood that the dose disclosed by Schrattenholz is sufficient for preventing Alzheimer’s disease and would have been interpreted as therapeutically effective.
In regards to the limitation wherein delaying onset of Alzheimer’s disease in the subject by repeated administration of the therapeutically effective amount of a muscarinic M2 receptor blocking compound to the subject and wherein the patient has not been diagnosed as currently experiencing Alzheimer’s disease at the time of administration of AAD23/muscarinic M2 receptor blocking compound as recited in claims 1, 7-8 and 14: Schrattenholz taught a method of preventing Alzheimer’s disease comprising administering a therapeutically effective amount of BIBN 99 (e.g., muscarinic M2 inhibitor). The methods of Schrattenholz are directed to preventing Alzheimer’s disease by administration of BIBN 99, which would have been understood to have a patient who may develop Alzheimer’s disease and which has not been diagnosed with the condition. The skilled artisan would have understood the methods of Schrattenholz meet the instant claim limitation of delaying the onset of Alzheimer’s disease since it taught the same active step of administering a muscarinic M2 inhibitor to patient identified to be who may develop Alzheimer’s disease. Therefore, one of ordinary skilled in the art would have found motivation to administer a muscarinic M2 receptor blocking compound to a patient for delaying the onset of Alzheimer’s disease because Schrattenholz administers a therapeutically effective amount of a muscarinic M2 blocking compound to a patient in need of prevention of Alzheimer’s disease. Further, motivation to administer the muscarinic M2 blocking compound repeatedly would have been resulted from Schrattenholz since it taught administration of a daily dose.
It would, therefore, have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention was made to use and modify the teachings of Schrattenholz in view of Eglen with reasonable expectation of success. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date.
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 1, 3-8, 10-15, and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-4 of U.S. Patent No. 11,801,241 B2 (hereinafter, ‘241 Patent’). Although the claims at issue are not identical, they are not patentably distinct from each other.
The ‘241 Patent recites a method that is more specific than the method of instant claim 1, in that reference claims 1-4 of ‘241 Patent recite a specific muscarinic inhibitor (e.g. AAD23) for a specific condition characterized by progressive memory decline (e.g. Alzheimer’s disease, Parkinson’s disease, Huntington’s disease, dementia) and for a specific patient population with a risk factor (e.g. GRK5 deficiency). Reference claim 1 of ‘241 is a “species” of the generic invention of instant claim 1, and therefore, a patent to the genus would improperly extend the right to exclude granted by a patent to the species or sub-genus should the genus issue as a patent after the species or sub-genus. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). See MPEP 804(II)(B)(1) and MPEP 804(II)(B)(2).
Conclusion
No claims are allowed.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUKE ALAN BORALSKY whose telephone number is (571)272-9746. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 am.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.A.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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