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 .
Claims 1-3, 7, 9, 10, 12, 14-16, 19-24, 33, 35, 56, and 72 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, 9, 10, 12, 14-16, 19-24, 33, and 56 in the reply filed on 09/30/2025 is acknowledged.
Claims 35 and 72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/30/2025.
Claims 1-3, 9, 10, 12, 14-16, 19-24, 33, and 56 are under current examination.
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.
Claims 1-3, 9, 10, 12, 14-16, 19-24, 33, and 56 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not reasonably provide enablement for the full scope of the claims.
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.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)).
These include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based
on the content of the disclosure
All of the Wands factors have been considered with regard to the instant claims
as discussed below:
(A)/(B) The breadth of the claims/The nature of the invention:
The claims are directed to a method of treating a disease by administering a therapeutically effective amount of a pharmaceutical composition comprising a CNS homing peptide with amino acid sequence of SEQID1-22 associated with an NSAID. The specification defines “treating” as “includ[ing] partially or completely delaying, alleviating, mitigating or reducing the intensity of one or more attendant symptoms of a disorder or condition and/or alleviating, mitigating or impeding one or more causes of a disorder or condition”. The specification defines the term “therapeutically effective” or “effective amount” as indicating “that a compound or material or amount of the compound or material when administered is sufficient or effective to prevent, alleviate, or ameliorate one or more symptoms of a disease, disorder or medical condition being treated, and/or to prolong the survival of the subject being treated”. Thus the full scope of the claims requires effective treatment or prevention of all diseases by administering the composition recited in the claims. The claims place no limitation on the identity of the disease and therefore the scope of the claim is astronomical. In order to practice the full scope of the invention, one having ordinary skill would need to know every subcategory of disease that would be susceptible to treatment or prevention by administration of the NSAID in association with the CNS homing peptide. The examiner notes that claim 33 further limits the identity of the disease to arthritis or a neuroinflammatory condition; however, this scope remains enormous as “neuroinflammatory condition” reads on anything from cancer metastases to the brain to possibly influencing loneliness and depression (Zhang, page 6, right col). As any type of cancer can metastasize to the brain (Mayo Clinic Website) the scope of treating cancer will be taken as exemplary, bearing in mind the actual breadth of the instant claims is much greater. According to the National Cancer Institute, "cancer'' embraces over 100 types of related proliferation disorders. Cancers are broadly classified into carcinoma, sarcoma, leukemia, lymphoma, multiple myeloma, melanoma, brain and spinal cord tumors, germ cell tumors, neuroendocrine tumors, and carcinoid tumors. Of these, only leukemia does not include solid tumors. Cancer types are subdivided by tissue of origin and are often subcategorized within that classification by histological markers or other clinical and histopathological features. See What is Cancer website, pages 4-7. In summary, the term “cancer” embraces hundreds of different diseases having different molecular mechanisms driving pathology and different responsiveness to therapies. Thus, the claims embrace preventing or effectively treating any of the over 100 different cancer types or any other disease. The scope of the claims is colossal.
(C)/(D) The state of the prior art/The level of predictability in the art:
The necessary steps to make and use the invention, as claimed, are to identify every subcategory that would respond to treatment or be prevented by administration of the claimed CNS homing peptide in association with an NSAID. The field of treating diseases with NSAIDS, delivered to the brain or just in general, was an area of intensive research as of the instant effective filing date and predictability is very low. Again, cancer metastasis will be taken as exemplary, because this condition falls within the scope of all claims as currently worded.
The ability to prevent metastasis was highly unpredictable and, although incidence may be reduced, one having ordinary skill in the art would have expected to be unable to prevent all metastases, particularly in cancers that had been discovered at a later stage or highly aggressive cancers (Bertolini, pages 1-2). Treating metastatic cancer is an enormous challenge in general. Kaplan explains that “[i]t could possibly be due to the basic biology of metastatic tumors and the lack of treatments that target their biology. For example, the genetic characteristics of metastatic tumors may make them highly resistant to standard treatments. Another thing is that each metastatic tumor may be growing in a different organ. This makes treatment a challenge because each tumor may have a unique tumor microenvironment and may respond differently to the treatment.” (Kaplan, NCI) A new approach as of the instant effective filing date was to attempt to prevent metastases with adjuvant chemotherapy by inter alia targeting the patient’s immune system. This methodology reduces incidence but does not prevent metastasis in all cases (Kaplan, NCI: whole document) and it remains an enormously challenging condition to treat (Kaplan, NCI; CRUK Cancer News). NSAIDs have been investigated for treatment and prevention of metastasis; however, in every case complete prevention of metastasis is not possible but rather risk is reduced (Zhao: abstract). In conclusion, one having ordinary skill would have found it impossible to predict a priori which metastatic cancer could have been prevented or effectively treated by administering an NSAID associated with a CNS homing peptide comprising SEQID1-22, and this would have been drastically more difficult for the full scope of the term “disease” recited in the instant claims.
The level of unpredictability in the art of drug development and patient treatment for any conditions, including cancer metastasis to the brain with a non-steroidal anti-inflammatory agent, is very high. In order to identify a pharmaceutical as both safe and effective for use in the general population, the skilled Artisan must validate the drug in pre-clinical testing, followed by phase I – III clinical trials to evaluate the drug's safety and efficacy in humans (Hughes, page 1240,figs 1 & 2). Each stage of this process is fraught with complexity. With regard to both practicing the invention for the full scope effectively treating or preventing any disease by administering a composition comprising a CNS homing peptide comprising SEQID1-22 that is associated with an NSAID, MPEP 2164.03 indicates that the physiological art in general is unpredictable. “A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work.” A similar statement appears at In re Application of Hozumi et al., 226 USPQ 353: "In spite of the vast expenditure of human and capital resources in recent years, no one drug has been found which is effective in treating all types of cancer. Cancer is not a simple disease, nor is it even a single disease, but a complex of a multitude of different entities, each behaving in a different way". There are compounds that treat a modest range of cancers, but no one has ever been able to figure out how to get a compound to be effective against cancer generally, or even a majority of cancers.
In summary, the field of treating and preventing diseases by administering NSAIDs, targeted to the brain or otherwise, was highly unpredictable, and the biological arts are unpredictable in general.
(D) The level of one of ordinary skill:
One having ordinary skill in the art would have an advanced degree in biomedical research and/or clinical practice such as a Ph.D. and/or an M.D., therefore the level of skill is high.
(F) The amount of direction provided by the inventor/(G) The existence of working examples:
The specification describes the composition in detail and states that the composition can achieve a pain relieving effect or achieve some other undefined “desired effect”. Several examples of diseases that could be treated are listed and the disease is described as follows:
The cell(s), the tissue(s), and/or organ(s) of the CNS can comprise damaged or inflamed cell(s), tissue(s), and/or organ(s). In some embodiments, the cell(s), tissue(s), and/or organ(s) of the CNS comprise the brain, the white matter, the gray matter, the brainstem, the cerebellum, the diencephalon, the cerebrum, the spinal cord, the cranial nerve, cell(s) of any of the preceding, tissue(s) of any of the preceding, or a combination thereof.
The description above reads on any disease and does not provide further guidance as to which diseases would respond or be prevented by treatment with the claimed composition comprising an NSAID in association with the claimed CNS homing peptides. Many if not all of the listed example diseases are not entirely preventable. The specification provides one example method wherein multiple sclerosis is treated in a mouse model; however, the examiner was unable to locate any description of the results of the study, therefore no examples showing prevention or effective treatment of multiple sclerosis have been provided. The specification does not provide further guidance on readily identifiable properties of a disease that would allow one of ordinary skill to readily discern susceptibility to the claimed method of effective treatment or prevention. Thus, given the unpredictability in the art, the amount of guidance in the specification regarding making/using the claimed composition for effective prevention or treatment of all diseases is not sufficient to enable one of ordinary skill to practice the full scope of the claimed invention.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
In view of the foregoing analysis, the quantity of experimentation to practice the full scope of the invention would be undue.
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.
Claims 1-3, 9, 10, 12, 14-16, 19-24, 33, and 56 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 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.
Applicant is referred to the Guidelines on Written Description published at FR 66(4) 1099-1111 (January 5, 2001) (also available at www.uspto.gov). The following passage is particularly relevant:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between structure and function, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within a genus, one must describe a sufficient number of species to reflect the variation within the genus. What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. In an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.
For Example MPEP 2163 states, in part,
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that “[w]ithout such disclosure, the claimed methods cannot be said to have been described.”).
The claims are directed to a method of treating a disease by administering a therapeutically effective amount of a pharmaceutical composition comprising a CNS homing peptide with amino acid sequence of SEQID1-22 associated with an NSAID.
With respect to the genus embraced by the claims, the phrase “treating a disease in a subject in need thereof comprising administering a therapeutically effective amount” is interpreted in view of the specification. The specification defines “treating” as “includ[ing] partially or completely delaying, alleviating, mitigating or reducing the intensity of one or more attendant symptoms of a disorder or condition and/or alleviating, mitigating or impeding one or more causes of a disorder or condition”. The specification defines the term “therapeutically effective” or “effective amount” as indicating “that a compound or material or amount of the compound or material when administered is sufficient or effective to prevent, alleviate, or ameliorate one or more symptoms of a disease, disorder or medical condition being treated, and/or to prolong the survival of the subject being treated”. Thus the full scope of the claims requires effective treatment or prevention of all diseases by administering the composition recited in the claims. The claims place no limitation on the identity of the disease and therefore the scope of the claim is astronomical. In order to practice the full scope of the invention, one having ordinary skill would need to know every subcategory of disease that would be susceptible to treatment or prevention by administration of the NSAID in association with the CNS homing peptide. The examiner notes that claim 33 further limits the identity of the disease to arthritis or a neuroinflammatory condition; however, this scope remains enormous as “neuroinflammatory condition” reads on anything from cancer metastases to the brain to possibly influencing loneliness and depression (Zhang, page 6, right col). As any type of cancer can metastasize to the brain (Mayo Clinic Website) the scope of treating cancer will be taken as exemplary, bearing in mind the actual breadth of the instant claims is much greater. According to the National Cancer Institute, "cancer'' embraces over 100 types of related proliferation disorders. Cancers are broadly classified into carcinoma, sarcoma, leukemia, lymphoma, multiple myeloma, melanoma, brain and spinal cord tumors, germ cell tumors, neuroendocrine tumors, and carcinoid tumors. Of these, only leukemia does not include solid tumors. Cancer types are subdivided by tissue of origin and are often subcategorized within that classification by histological markers or other clinical and histopathological features. See What is Cancer website, pages 4-7. In summary, the term “cancer” embraces hundreds of different diseases having different molecular mechanisms driving pathology and different responsiveness to therapies. Thus, the claims embrace preventing or effectively treating any of the over 100 different cancer types. The scope of the claims is colossal.
With respect to disclosure of a representative number of species, the level of skill of an artisan in the field of disease treatment and prevention as well as the level of knowledge in the prior art and the predictability of the prior art must be considered. The artisans of skill in the field disease prevention and treatment would be a collaborative team of materials scientists, physicians, and/or biologists possessing an advanced degree in biomedicine and/or a doctor of medicine degree, thus the level of skill is high. The level of unpredictability in the art is also very high, again taking cancer as exemplary:
The ability to prevent metastasis was highly unpredictable and although incidence may be reduced, one having ordinary skill in the art would have expected to be unable to prevent all metastases, particularly in cancers that had been discovered at a later stage or highly aggressive cancers (Bertolini, pages 1-2). Treating metastatic cancer is an enormous challenge in general. Kaplan explains that “[i]t could possibly be due to the basic biology of metastatic tumors and the lack of treatments that target their biology. For example, the genetic characteristics of metastatic tumors may make them highly resistant to standard treatments. Another thing is that each metastatic tumor may be growing in a different organ. This makes treatment a challenge because each tumor may have a unique tumor microenvironment and may respond differently to the treatment.” (Kaplan, NCI) A new approach as of the instant effective filing date was to attempt to prevent metastases with adjuvant chemotherapy by inter alia targeting the patient’s immune system. This methodology reduces incidence but does not prevent metastasis in all cases (Kaplan, NCI: whole document) and it remains an enormously challenging condition to treat (Kaplan, NCI; CRUK Cancer News). NSAIDs have been investigated for treatment and prevention of metastasis; however, in every case complete prevention of metastasis is not possible but rather risk is reduced (Zhao: abstract). In conclusion, one having ordinary skill would have found it impossible to predict a priori which metastatic cancer could have been prevented or effectively treated by administering an NSAID associated with a CNS homing peptide comprising SEQID1-22, and this would have been drastically more difficult for the full scope of the term “disease” recited in the instant claims.
The level of unpredictability in the art of drug development and patient treatment for any conditions, including cancer metastasis to the brain with a non-steroidal anti-inflammatory agent, is very high. In order to identify a pharmaceutical as both safe and effective for use in the general population, the skilled Artisan must validate the drug in pre-clinical testing, followed by phase I – III clinical trials to evaluate the drug's safety and efficacy in humans (Hughes, page 1240,figs 1 & 2). Each stage of this process is fraught with complexity.
Thus, one having ordinary skill would again need to empirically delineate which diseases could be effectively treated or prevented by administration of an NSAID associated with CNS homing peptides having SEQID1-22. The state of the art fails to remedy the deficiencies under 35 USC 112(a) in terms of establishing applicant was in possession of the full scope of the claimed invention. In summary, the field of treating and preventing diseases by administering NSAIDs, targeted to the brain or otherwise, was highly unpredictable, and the biological arts are unpredictable in general.
As noted above, in order to satisfy the written description requirement under 35 USC 112(a), the original disclosure may provide a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between structure and function, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
In the instant case, no drawings have been made of record. The specification describes the composition in detail and states that the composition can achieve a pain relieving effect or achieve some other undefined “desired effect”. Several examples of diseases that could be treated are listed and the disease is described as follows:
The cell(s), the tissue(s), and/or organ(s) of the CNS can comprise damaged or inflamed cell(s), tissue(s), and/or organ(s). In some embodiments, the cell(s), tissue(s), and/or organ(s) of the CNS comprise the brain, the white matter, the gray matter, the brainstem, the cerebellum, the diencephalon, the cerebrum, the spinal cord, the cranial nerve, cell(s) of any of the preceding, tissue(s) of any of the preceding, or a combination thereof.
The description above reads on any disease and does not provide further guidance as to which diseases would respond or be prevented by treatment with the claimed composition comprising an NSAID in association with the claimed CNS homing peptides. Many if not all of the listed example diseases are not entirely preventable. The specification provides one example method wherein multiple sclerosis is treated in a mouse model; however, the examiner was unable to locate any description of the results of the study, therefore no examples showing prevention or effective treatment of multiple sclerosis have been provided. The specification does not provide further guidance on readily identifiable properties of a disease that would allow one of ordinary skill to readily discern susceptibility to the claimed method of effective treatment or prevention. Thus, given the unpredictability in the art, the amount of guidance in the specification regarding making/using the claimed composition for effective prevention or treatment of all diseases is not sufficient to enable one of ordinary skill to practice the full scope of the claimed invention.
The description of a single species of disease that may administration of the claimed composition comprising an NSAID associated with a CNS homing peptide comprising SEQID1-22, as well as the low predictability regarding which disease might respond to such a composition supports the conclusion that Applicant has not provided sufficient written description to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the claimed invention. This is also the case because although multiple sclerosis was described, no data was presented showing that the claimed composition has any effect on this condition, let alone that it could effectively treat or prevent multiple sclerosis. The intended outcome recited in instant claim 15 “treating” by administering an “effective amount”, which both embrace effectively treating or preventing, appears to be merely a wish or plan for obtaining the invention as claimed, consistent with the patent at issue in University of Rochester vs. G.D. Searle & Co. In view of the foregoing the claims are rejected under 35 USC 112(a) as failing to satisfy the written description requirement.
Claim Rejections - 35 USC § 112
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 2, 3, 7, 9, 10, 19, 20-24 and 56 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.
Claim 2 requires that the CNS homing peptide is directly or indirectly associated with the NSAID. The phrase “indirectly associated” is so vague in this context as to render the claim indefinite. The claim requires an association; however, what falls in or outside of the phrase “indirectly associated” provides no guidance as to what relationship between the peptide and the NSAID fall within the scope of the claims. For example, given its plain meaning, the term could read on containers comprising the NSAID and the peptide with nothing binding them together; however, in view of the specification one having ordinary skill would expect some degree of permanence to the association such that the NSAID would effectively be targeted to the CNS by the peptide. Clarification is required.
Claim 12 requires that the weight ratio, or the molar ratio, or both, be about 10:1 to 1:10. Unless two substances have identical molar masses, their weight and molar ratios cannot be identical therefore the claim is internally contradictory.
Claims 19 and 21-24 each recite a limitation on the percentage of NSAID that is therapeutically effective in the claimed method in terms of a percentage of an undefined “therapeutic amount” of an NSAID “administered in the absence of the CNS homing peptide or when the NSAID is administered alone”. The conditions under which the relative amount of NSAID is administered in terms of condition being treated, identity of the NSAID, and method of NSAID delivery are totally undefined by the claim, thus no actual efficacy of the comparative NSAID has been identified by the current claim language. Therefore it is unclear whether there is actually any meaningful limitation on amount of NSAID associated with the CNS homing peptide in the claimed method, either relatively or absolutely, imposed by this language. In other words, the language appears to be intended to limit the therapeutic efficacy of the claimed method relative to another method of delivering an NSAID; however, the actual limitation imposed by this language cannot be determined.
Claims 20, 21, and 56 each require a “desired effect”; however, the effect is not identified, nor is the identity of the individual who desires it. Thus the claim requires an outcome, but the outcome is undefined and therefore the claim is indefinite.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Claim Rejections - 35 USC § 112
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 7, 9, and 10 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.
In this case, claim 7 fails to further limit the subject matter of the claim upon which it depends. The method of claim 1 is interpreted under 35 USC 112 to contain only the method steps recited in the claims (i.e. only administering a composition having the CNS homing peptide associated with the NSAID). Thus, claims 7 fails to further limit claim 1 because the method delineated in claim 1 does not contain any further elements in the composition other than the NSAID and the CNS homing peptide. Any claim that recites additional elements that must be present in a process must recite the transitional phrase “further comprising” under 35 USC 112. 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.
Amending the transitional phrase in claim 7 to recite “further comprising” in place of “comprising” would place the claims in proper dependent form.
Claim 10 fails to include all of the limitations of the claim from which it depends because claim 7 requires the CNS homing peptide to be on an outer surface of a delivery vehicle; however, substances such as surfactants or phospholipids do not themselves have an outer surface in the manner required by claim 7 (i.e. such that a peptide could be considered to be “on the outer surface” the vehicle).
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.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the improper dependency concerns outlined above.
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, 9, 10, 12, 14-16, 19-24, 33, and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Moudgil et al. (WO 2018/132467; publication date: 07/19/2018; cited in the IDS filed 04/20/2023).
With regard to claim 1, Moudgil discloses a method of treating the disease neuroinflammation in a subject by administering an effective amount of a central nervous system (CNS) homing peptide in combination with a therapeutic agent (page 5). The CNS homing peptides contain amino acid sequences identical to the instant SEQID 1-22 (pages 3-4). The homing peptide can be conjugated to a surface of a liposome (i.e. a vehicle, which together with the therapeutic agent form a composition; page 5). Drug can be incorporated into the liposome (page 18).
Although Moudgil does not disclose a single example containing an NSAID, Moudgil indicates that this class of drugs can be delivered using their system (page 22). It would have been prima facie obvious to deliver an NSAID using Moudgil’s system because such was within the scope of the disclosed invention.
With regard to claims 2 and 3, the drug molecule can be linked to the homing peptide via covalent bonds or non-covalent bonds (this falls within the scope of “directly or indirectly linked”; page 15).
With regard to instant claims 7, 9, and 10, the homing peptide can be conjugated to a surface of a liposome (i.e. a vehicle, which together with the therapeutic agent form a composition; page 5). Drug can be incorporated (i.e. enclosed) into the liposome (page 18).
With regard to claims 12 15, and 16, Moudgil discloses composition comprising an effective amount of a central nervous system homing peptide according to any of claims 1-30 or a composition of any of claims 31-47, in combination with an effective amount of a therapeutic agent, wherein the homing peptide facilitates the delivery of the therapeutic agent to inflamed central nervous system tissue (claim 53). This directs one of ordinary skill to discern the amount of peptide for effective delivery and the amount of drug for effective treatment of the neuroinflammation. The examiner does not consider the ranges in amount or ratio of homing peptide to NSAID to patentably define over the cited prior art, because it would have been routine for one of ordinary skill to optimize the amounts of each substance (and thus also their ratio to one another) to achieve the stated goal of Moudgil of delivery to the CNS and treatment of neuroinflammation (see MPEP 2144.05).
With regard to claim 14, the NSAID may be ibuprofen, naproxen, meloxicam, etodolac, nabumetone, sulindac, tolementin, choline magnesium salicylate, diclofenac, diflusinal, indomethicin, ketoprofen, oxaprozin, piroxicam, and nimesulide, salicylates, aspirin (acetyl salicylic acid), diflunisal, salsalate, p-amino phenol derivatives, paracetamol, phenacetin, propionic acid derivatives, fenoprofen, flurbiprofen, oxaprozin, loxoprofen, acetic acid derivatives, indomethacin, sulindac, etodolac, ketorolac, nabumetone, enolic acid (oxicam) derivatives, piroxicam, meloxicam, tenoxicam, droxicam, lornoxicam, isoxicam, fenamic acid derivatives (fenamates), mefenamic acid, meclofenamic acid, flufenamic acid, tolfenamic acid, selective COX-2 inhibitors (coxibs), celecoxib, rofecoxib, valdecoxib, parecoxib, lumiracoxib, etoricoxib, firocoxib, sulphonanilides, nimesulide, licofelone (page 22).
With regard to claims 16, 19-24, and 56, Moudgil discloses that an effective amount is administered and characterizes “effective amount” as an amount of the peptide that alleviates, totally or partially, neuroinflammation in a subject or a subject at risk of developing neuroinflammation (page 21). Thus, one of ordinary skill is directed to find a dose that will achieve some alleviation of the symptoms of neuroinflammation. Moudgil provides the further guidance that the effective dose will depend on subject’s size, gender magnitude of disease/condition, as well as genetic and non-genetic factors associated with pharmacokinetic or pharmacodynamic properties of the administered peptide. Moudgil discloses that one of ordinary skill can determine these parameters by methods known in the art (page 21). Thus, it would have been merely routine for one of ordinary skill to optimize dosing parameters to deliver the drug in conjunction with the homing peptide disclosed by Moudgil to achieve a desired therapeutic effect, along with the corresponding pharmacokinetic and pharmacodynamic profile. See MPEP 2144.05.
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, 9, 10, 12, 15, 16, 19-24, 33, and 56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1-9, 13, 24, 28, 31-35, 37, 55, and 56 of copending Application No. 18257014 (reference application); and
claims 1-3, 7, 9, 10, 12, 13, 17-25, 32, 64 of copending Application No. 18004400 (reference application);
as evidenced by Lazur et al. (Antioxidants 12, 623; publication year: 2023).
Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons set forth below:
Inter alia, the claims of the copending applications embrace a method of treating a disease by administering a CNS homing peptide having the sequences identical to instant SEQID1-22 in association with psilocybin, which has anti-inflammatory properties and is not a steroid therefore falls within the scope of NSAID (see Lazur: page 7, which states that psilocybin decreases TNF-a and IL-1b and therefore has anti-inflammatory effects). The psilocybin may be covalently or non-covalently attached to the homing peptide in a composition also comprising a vehicle that is a liposome, surfactant, phospholipid (see page 3 of the ‘014 application where it is indicated that the term “vehicle” embraces phospholipids or surfactants or a liposome). The examiner considers it prima facie obvious to optimize the ratios of CNS homing peptide to psilocybin to achieve the treatment goal within the limitations of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 9, 10, 12, 14-16, 19-24, 33, and 56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 16, 19, 27-30, 33-35, 37, 42, 49, 59, 65, 71, and 76-78 of copending Application No. 18004546 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims anticipate the instant claims.
Inter alia, the claims of the ‘546 application embrace a method of treating a disease in a subject in need thereof comprising a composition comprising a CNS homing peptide having sequence identical to instant SEQID1-22 associated with an NSAID in molar ratios identical to those claimed and exhibiting the same pharmacokinetic profile as the method of the instant application. The NSAIDs are aspirin diflunisal, salicylic acid, salsalate, ibuprofen, dexibuprofen, naproxen, fenoprofen, ketoprofen, dexketoprofen, flurbiprofen, oxaprozin, loxoprofen, indomethacin, tolmetin, sulindac, etodolac, ketorolac, diclofenac, aceclofenac, bromfenac, nabumetone, piroxicam, meloxicam, tenoxicam, droxicam, lornoxicam, isoxicam, phenylbutazone (bute), mefenamic acid, meclofenamic acid, flufenamic acid, tolfenamic acid, celecoxib, rofecoxib, valdecoxib, parecoxib, lumiracoxib, etoricoxib, firocoxib, nimesulide, clonixin, licofelone, H- harpagide, or a combination thereof. The peptide is on the surface of a delivery vehicle which contains the drug (see page 9 of the ‘546 application where it is indicated that the term “vehicle” embraces phospholipids or surfactants or a liposome).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617