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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group I, and species of Hybrid I of SEQ ID NO:2 and pruritus, in the reply filed on 11/19/25 is acknowledged.
Claim Status
Claims 9, 11, 20, 23, and 25 are cancelled. Claims 1-8, 10, 12-19, 21-22, and 24 are pending.
Claims 12-19, 21-22, and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 2, 4, 7, and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/19/25.
Claims 1, 3, 5-6, and 8 are currently under consideration for patentability under 37 CFR 1.104.
Information Disclosure Statement
The information disclosure statements filed on 12/13/22, 2/25/25, and 6/24/25 have been considered. Signed copies are enclosed.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
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
Claims 1, 3, 5-6, and 8 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.
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 lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
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, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicants were in possession of the claimed genus.
The instant claims are directed to a method for treatment and/or prophylaxis of pruritus, prurigo, neutrophilic dermatoses, or skin cancer comprising administering interferon-alpha14, HYBRID 1, HYBRID 2, or a combination thereof. The terms “HYBRID 1” and “HYBRID 2” are indefinite as described under 35 USC 112(b) below. The claims indicate that the HYBRID proteins can include any “functionally active fragment or variant thereof.” These fragments or variants are not adequately described, and therefore the method encompassing the administration of the proteins is not adequately described. The proteins must have specific functions, including treatment or prophylaxis of several diseases, and functioning as an interferon alpha subtype. Furthermore, the protein fragments, and possibly the variants, must also be “functionally active” although this term is indefinite (see rejection under 35 USC 112(b) below).
The specification discloses SEQ ID NO:1-3 as having the required functions. However, the claim encompasses proteins that are “functionally active fragments and variants” of these proteins, which could include a large number of possible variants and fragments, and the variability is expanded even further by the open ended transitional phrase “comprising” which allows for protein sequences to be attached to the fragments and variants. These peptides have no correlation between their structure and function. The specification provides no guidance regarding which variants or fragments are capable of the required function. Therefore, the specification provides insufficient written description to support the genus encompassed by the claim. Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that
"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.)
With the exception of SEQ ID NO:1-3, the skilled artisan cannot envision the detailed chemical structure of the encompassed polypeptides, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The nucleic acid and/or protein itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2datl966.
Protein chemistry is one of the most unpredictable areas of biotechnology. This unpredictability prevents prediction of the effects that a given number or location of mutation will have on a protein (such as TNF or a cytokine) As taught by Skolnick et al (Trends Biotechnol. 2000 Jan;18(1):34-9), sequence based methods for predicting protein function are inadequate because of the multifunctional nature of proteins (see e.g. abstract). Further, just knowing the structure of the protein is also insufficient for prediction of functional sites (see e.g. abstract). Sequence to function methods cannot specifically identify complexities for proteins, such as gain and loss of function during evolution, or multiple functions possible within a cells (see e.g. page 34, right column). Skolnick advocates determining the structure of the protein, then identifying the functionally important residues since using the chemical structure to identify functional sites is more in line with how a protein actually works (see e.g. page 34, right column).
The sensitivity of proteins to alterations of even a single amino acid in a sequence are exemplified by Burgess et al. (J. Cell Biol. 111:2129-2138, 1990) who teach that replacement of a single lysine reside at position 118 of acidic fibroblast growth factor by glutamic acid led to the substantial loss of heparin binding, receptor binding and biological activity of the protein and by Lazar et al. (Mol. Cell. Biol., 8:1247-1252, 1988) who teach that in transforming growth factor alpha, replacement of aspartic acid at position 47 with alanine or asparagine did not affect biological activity while replacement with serine or glutamic acid sharply reduced the biological activity of the mitogen. These references demonstrate that even a single amino acid substitution will often dramatically affect the biological activity and characteristics of a protein.
Further, Miosge (Proc Natl Acad Sci U S A. 2015 Sep 15;112(37):E5189-98) teach that Short of mutational studies of all possible amino acid substitutions for a protein, coupled with comprehensive
functional assays, the sheer number and diversity of missense mutations that are possible for proteins means that their functional importance must presently be addressed primarily by computational inference (see e.g. page E5189, left column). However, in a study examining some of these methods, Miosge shows that there is potential for incorrect calling of mutations (see e.g. page E5196, left column, top paragraph). The authors conclude that the discordance between predicted and actual effect of missense mutations creates the potential for many false conclusions in clinical settings where sequencing is performed to detect disease-causing mutations (see e.g. page E5195, right column, last paragraph). The findings in their study show underscore the importance of interpreting variation by direct experimental measurement of the consequences of a candidate mutation, using as sensitive and specific an assay as possible (see e.g. page E5197, left column, top paragraph). Additionally, Bork (Genome Research, 2000,10:398-400) clearly teaches the pitfalls associated with comparative sequence analysis for predicting protein function because of the known error margins for high-throughput computational methods. Bork specifically teaches that computational sequence analysis is far from perfect, despite the fact that sequencing itself is highly automated and accurate (p. 398, column 1). One of the reasons for the inaccuracy is that the quality of data in public sequence databases is still insufficient. This is particularly true for data on protein function. Protein function is context dependent, and both molecular and cellular aspects have to be considered (p. 398, column 2). Conclusions from the comparison analysis are often stretched with regard to protein products (p. 398, column 3). Further, although gene annotation via sequence database searches is already a routine job, even here the error rate is considerable (p. 399, column 2). Most features predicted with an accuracy of greater than 70% are of structural nature and, at best, only indirectly imply a certain functionality (see legend for table 1, page 399). As more sequences are added and as errors accumulate and propagate it becomes more difficult to infer correct function from the many possibilities revealed by database search (p. 399, paragraph bridging columns 2 and 3). The reference finally cautions that although the current methods seem to capture important features and explain general trends, 30% of those features are missing or predicted wrongly. This has to be kept in mind when processing the results further (p. 400, paragraph bridging cols 1 and 2).
One key issue is the prediction of protein function based on sequence similarity, which could be one way to identify the functional fragments and variants that are useful in the instant claims. Kulmanov et al (Bioinformatics, 34(4), 2018, 660–668), teach that there are key challenges for protein function prediction methods (see e.g. page 661, left column). These challenges arise from the difficulty identifying and accounting for the complex relationship between protein sequence structure and function (see e.g. page 661, left column). Despite significant progress in the past years in protein structure prediction, it still requires large efforts to predict protein structure with sufficient quality to be useful in function prediction (see e.g. page 661, left column). Another challenge is that proteins do not function in isolation. In particular higher level physiological functions that go beyond simple molecular interactions will require other proteins and cannot usually be predicted by considering a single protein in isolation (see e.g. page 661, left column). Due to these challenges it is not obvious what kinds of features should be used to predict the functions of a protein and whether they can be generated efficiently for a large number of proteins, such as the vast genus of proteins encompassed by the instant claims (see e.g. page 661, left column).
Given the teachings of these references that point out the limitations and pitfalls of using sequence to predict functions, and the lack of a representative number of species across the breadth of the genus, one of skill in the art would reasonably conclude that only SEQ ID NO:1-3, but not the full breadth of the claims, meet the written description provision of 35 USC 112(a).
Adequate written description requires more than a mere statement that is part of the invention. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chungai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
The University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: …To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines Inc. 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus an Applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2dat1966.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow person of ordinary skill in the art to recognize that he or she invented what is claimed’”. The courts have decided: the purpose of the "written description" requirement is broader than to merely explain how to "make and use"; 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 Vas-Cath, Inc v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).
Furthermore, the written description provision of 35 USC §112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993). And Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Moreover, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has the Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Therefore for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
Enablement
Claims 1, 3, 5-6, and 8 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is noted that MPEP 2164.03 teaches that “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability of the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The amount of guidance or direction refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as how to make and use the invention in order to be enabling.”
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue include, but are not limited to (In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)):
1) nature of the invention;
2) the breadth of the claims;
3) the state of the prior art;
4) the level of one of ordinary skill;
5) the level of predictability in the art;
6) the amount of direction or guidance provided by the inventor;
7) the existence of working examples; and
8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
1) nature of the invention; 2) the breadth of the claims;
The instant claims are directed to a method for treatment and/or prophylaxis of pruritus, prurigo, neutrophilic dermatoses, or skin cancer comprising administering interferon-alpha14, HYBRID 1, HYBRID 2, or a combination thereof. The terms “HYBRID 1” and “HYBRID 2” are indefinite as described under 35 USC 112(b) below. The claims indicate that the HYBRID proteins can include any “functionally active fragment or variant thereof.” Furthermore, the protein fragments, and possibly the variants, must also be “functionally active” although this term is indefinite (see rejection under 35 USC 112(b) below). These terms potentially encompass a very large number of possible variants and fragments, which are defined only by an inadequately described function.
The claims encompass treatment and prophylaxis of four completely separate genera of disorders that are characterized by separate pathology and etiology, for which there are no known agents that treat all of the encompassed disorders. The encompassed disorders are highly heterogeneous at both the molecular and clinical level. Further, the claims are directed to prevention of the disorders.
3) the state of the prior art; 5) the level of predictability in the art;
The lack of significant guidance from the present specification or prior art with regard to the actual treatment of the encompassed diseases in a subject, with the claimed genus of proteins, makes practicing the invention unpredictable.
Predicting whether or not an agent will be able to treat a particular disease is fraught with obstacles, even if the patient population has a well-understood disease. As taught by Ma (Modern Drug Discovery 2004, 7(6)), any results from in vitro screening often poorly correlate with in vivo results because the complicated physiological environment is absent in the in vitro system (see page 30, left column).
In addition, predicting the success of a treatment for the encompassed disorders presents challenges beyond initial screening. For example, as taught in Shah et al (Current Dermatology Reports (2022) 11:146–157), the term neutrophilic dermatoses represents a heterogeneous group of disorders (see e.g. abstract). Diagnosis for these disorders can be difficult, leading to challenges in identifying appropriate treatment (see e.g. page 151, left column). These disorders can be difficult to manage (see e.g. page 151, right column). For example, Pyoderma Gangrenosum is extremely difficult to manage, and only two published randomized clinical trials examining treatments for the disease exist, and current treatments are largely based on anecdotal data and case studies (see e.g. page 151, right column).
Additionally, Parekh et al (“Pruritus and Systemic Disease,” downloaded from https://emedicine.medscape.com/article/1098029-overview, published 7/17/25) teaches that pruritus management is difficult, and is often caused from systemic disease (see e.g. entire reference). Treatment for pruritus of systemic disease varies according to underlying cause, and without eradication of the underlying systemic disease, treatment is often palliative at best (see e.g. entire reference). According to Pereira et al (Acta Dermato-Venereologica, 100(2), 45–51), pruritus affects a large number of individuals, and those affected often report a substantial burden and a relevant impairment of their quality of life (see e.g. page 45). The multidimensional nature of this condition and the heterogeneous population affected by the disorder pose a challenge for clinical researchers and attending physicians (see e.g. page 49-50 “Conclusion”). Unmet needs, such as the shortage of knowledge on chronicity mechanisms, insufficient standardization of a diagnostic and therapeutic approach to pruritus patients, and the lack of development of novel promising drugs for treatment, pose challenges to predicting treatments for the disease (see e.g. page 49-50 “Conclusion”).
Regarding the treatment and prevention of skin cancer, the cancer treatment art involves a very high level of unpredictability.
Bally et al. (US 5,595,756) stated, “Despite enormous investments of financial and human resources, no cure exists for a variety of diseases. For example, cancer remains one of the major causes of death. A number of bioactive agents have been found, to varying degrees, to be effective against tumor cells. However, the clinical use of such antitumor agents has been highly compromised because of treatment-limiting toxicities” (col. 1, lines 17-24).
Sporn et al, “Chemoprevention of Cancer,” Carcinogenesis, Vol. 21 (2000), 525-530, teaches the magnitude of mortality of cancers and that mortalities are in fact still rising and that new approaches to a variety of different cancer are critically needed. Sporn et al also teaches that “given the genotype and phenotype heterogeneity of advanced malignant lesions as they occur in individual patients, one wonders just exactly what are the specific molecular and cellular targets for the putative cure.”
Furthermore, the art indicates the difficulties in going from in vitro to in vivo for drug development for treatment of cancers. Auerbach et al (Cancer and Metastasis Reviews, 2000, 19: 167-172) indicates that one of the major problems in angiogenesis research has been the difficulty of finding suitable methods for assessing the angiogenic response. For example, the 96 well rapid screening assay for cytokinesis was developed in order to permit screening of hybridoma supernatants…In vitro tests in general have been limited by the availability of suitable sources for endothelial cells, while in vivo assays have proven difficult to quantitate, limited in feasibility, and the test sites are not typical of the in vivo reality (see p. 167, left column, 1st paragraph). Gura T (Science, 1997, 278(5340): 1041-1042, encloses 1-5) indicates that “the fundamental problem in drug discovery for cancer is that the model systems are not predictive at all” (see p. 1, 2nd paragraph). Furthermore, Gura T indicates that the results of xenograft screening turned out to be not much better than those obtained with the original models, mainly because the xenograft rumors don’t behave like naturally occurring tumors in humans—they don’t spread to other tissues, for example (see p. 2, 4th paragraph). Further, when patient’s tumor cells in Petri dishes or culture flasks and monitor the cells’ responses to various anticancer treatments, they don’t work because the cells simply fail to divide in culture, and the results cannot tell a researcher how anticancer drugs will act in the body (see p. 3, 7th paragraph). Furthermore, Jain RK (Scientific American, July 1994,58-65) indicates that the existing pharmacopoeia has not markedly reduced the number of deaths caused by the most common solid tumors in adults, among them cancers of the lung, breast, colon, rectum, prostate and brain (see p. 58, left most column, 1st paragraph). Further, Jain RK indicates that to eradicate tumors, the therapeutic agents must then disperse throughout the growths in concentrations high enough to eliminate every deadly cells…solid cancers frequently impose formidable barriers to such dispersion (see p. 58, bottom of the left most column continuing onto the top of the middle column). Jain RK indicates that there are 3 critical tasks that drugs must do to attack malignant cells in a tumor: 1) it has to make its way into a microscopic blood vessel lying near malignant cells in the tumor, 2) exit from the vessel into the surrounding matrix, and 3) migrate through the matrix to the cells. Unfortunately, tumors often develop in ways that hinder each of these steps (see p. 58, bottom of right most column). Further, as taught by HogenEsch et al (J Control Release. 2012 December 10; 164(2): 183–186.) There is no single cell culture or in vivo cancer model that faithfully predicts the efficacy of
anticancer drugs in human clinical trials. Cell culture approaches offer the advantage of human-derived cell lines or tissue fragments from primary tumors, but cannot mimic the complexity of the reciprocal interaction between the growing tumor and the co-evolving microenvironment. Xenografts in immunodeficient mice have limited added value over cell culture models as the lack of an intact immune system and insufficient interactions between the human tumor cells and mouse stromal cells do not recapitulate human cancers. Thus, the art recognizes that going from in vitro studies to in vivo studies for cancer drug developments are difficult to achieve.
6) the amount of direction or guidance provided by the inventor; 7) the existence of working examples;
The instant specification provides two working examples. Example 1 tests the effect of IFNalpha-14 on IL-6 and CXCL8 production in keratinocytes isolated from normal human skin. Example 2 shows the effect of IFN-alpha14, HYBRID 1, and HYBRID 2 on IL31 productions in human leukocytes isolated from human blood. Notably, both examples use only in vitro assays to test molecular effects. The specification does not provide any in vivo data regarding administration of any of the encompassed IFN proteins to any subject. Further, there is no example of administration of any of the encompassed IFN proteins to treat or prevent any disorder, and no evidence has been presented that shows that the encompassed proteins are capable of in vivo functions. This leaves one of skill in the art to first screen for possible variants and fragments that have “function”, despite not knowing what type of function is required, then testing the variants and fragments in models of the various genera of disorders, which include all types of skin cancers, all types of neutrophilic dermatoses, and pruritus developed from any possible underlying cause, to determine which proteins could have a therapeutic or prophylactic effect. This level of required experimentation rises to the level of undue experimentation.
In conclusion, the claimed invention does not provide enablement for treating or preventing the encompassed disorders with the very broad genera of IFN proteins that are encompassed by the claims. Thus for the reasons outlined above, the specification is not considered to be enabling for one skilled in the art to make and use the claimed invention as the amount of experimentation required is undue, due to the broad scope of the claims, the lack of guidance and working examples provided in the specification. Therefore, the specification is not representative of the instant claims and the specification is not fully enabled for the instant claims. In view of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention.
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, 5-6, and 8 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 1 recites “treatment and/or prophylaxis”. It is impossible to have both treatment and prophylaxis at the same time. The disease is present to be treated, or the patient is administered the agent for prophylaxis. The scope of the claim is therefore indefinite.
Claim 1 recites “a subject in need thereof”. It is unclear which criteria would be required to identify such as subject, especially with regard to prophylaxis.
Claims 1 and 3 recite the term “HYBRID”. However, this term is not adequately defined in the specification or the claims. The term is arbitrary, and it is unclear exactly which proteins are encompassed by the term. Notably, the instant specification provides at least two possible definitions for the HYBRID proteins, which either are directed to specific sequences designated by SEQ ID NO (see e.g. instant specification page 5, lines 20-32, which, for example, defines “HYBRID 1” to be SEQ ID NO:2), or which encompass functionally active fragments or variants thereof (see e.g. claim 3). Therefore it is unclear what is encompassed by the term “HYBRID” within the claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation “comprises”, and the claim also recites “consists” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 3 recites the phrase “comprises or consists of an amino acid sequence SEQ ID NO:2”. It is unclear if the term encompasses only the exact sequence set forth in SEQ ID NO:2, or if the term “an amino acid sequence” can encompass any two peptides in sequence together that are listed within the sequence of SEQ ID NO:2.
Claim 3 recites “functionally active fragment or variant thereof”. There are two issues with this language. First, it is unclear if the variant must also be “functionally active”, or if the functional limitation only applies to the fragments. Second, it is unclear what criteria must be met to be considered “functionally active”, such as which “function” must be present in the protein.
The term “low” in claim 6 is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claim 3 is 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 3 recites “wherein the interferon alpha subtype HYBRID 1 comprises or consists of an amino acid sequence SEQ ID NO:2 or a functionally active fragment or variant thereof.” However, the specification defines “HYBRID 1” to be SEQ ID NO:2 (see instant specification page 5, lines 20-32). The recitation of “a functionally active fragment or variant thereof” potentially broadens the claim scope compared to the base claim, and therefore fails to further limit the subject matter of the claim upon which it depends.
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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5-6, and 8 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Stimson (WO 2015/136287 A2; filed 3/12/15; published 9/17/15), as evidenced by Kabashima (Journal of Dermatological Science 70 (2013) 3–11).
Instant claim 1 is directed to a method for the treatment and/or prophylaxis of pruritus, prurigo, neutrophilic dermatoses or skin cancer, said method comprising the step of: (i) administering to a subject in need thereof a therapeutically effective amount of an interferon alpha subtype, wherein the interferon alpha subtype is IFN-al4, HYBRID 1, HYBRID 2 or a combination of at least two of IFN-cd4, HYBRID 1 and HYBRID 2.
Instant claim3 is directed to the method of claim 1, wherein the interferon alpha subtype HYBRID 1 comprises or consists of an amino acid sequence SEQ ID NO:2 or a functionally active fragment or variant thereof.
Instant claim 5 is directed to the method of any preceding claim 1, wherein the method of administration is selected from topical administration and sublingual administration.
Instant claim 6 is directed to the method of any preceding claim 1, wherein the therapeutically effective amount of the interferon alpha subtype is a low dose.
Instant claim 8 is directed to the method of any preceding claim 1 for treatment of a condition selected from pruritus, prurigo, or neutrophilic dermatoses.
Regarding the limitations of instant claim 1 and 8, Stimson teaches methods to suppress a humoral or allergic immune response mediated by Th2 and Th17 cells, and particular for preventing or treating allergy and associated allergic diseases or cancer (see e.g. Stimson abstract). The Th2-predominant immune response includes itchiness (see e.g. Stimson page 5). The method can comprise administering IFN-alpha14 to treat skin cancer or melanoma (see e.g. Stimson page 7, lines 19-29). The method can also be used to treat or prevent diseases such as atopic dermatitis (see e.g. Stimson page 22, lines 1-5). As evidenced by Kabashima, atopic dermatitis is a disorder characterized by intense pruritus (see e.g. Kabashima, page 4, left column under “Introduction”). Furthermore, it is noted that the instant claims recite “prophylaxis” is not defined in the specification, but when given its general meaning, the term refers to action taken to prevent disease. To administer prophylactically requires that no disease is currently present during the administration. Therefore, the claims read on treatment of diseases like skin cancer and pruritus, but also on administering to any individual, including those that do not have those diseases, which will inherently prevent the disease upon administration.
Regarding the limitations of instant claim 3, Stimson teaches that the IFN-alpha14 can consist of the amino acid sequence of SEQ ID NO:1 (see e.g. page 10, lines 1-2), which is identical to instant SEQ ID NO:2, as shown in the alignment below (Qy represents instant SEQ ID NO:2, and Db represents Stimson SEQ ID NO:1):
Query Match 100.0%; Score 854; Length 166;
Best Local Similarity 100.0%;
Matches 166; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 CDLPQTHSLGNRRALILLGQMGRISPFSCLKDRHDFRIPQEEFDGNQFQKAQAISVLHEM 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 CDLPQTHSLGNRRALILLGQMGRISPFSCLKDRHDFRIPQEEFDGNQFQKAQAISVLHEM 60
Qy 61 MQQTFNLFSTENSSAAWEQTLLEKFSIELFQQMNDLEACVIQEVGVEETPLMNEDSILAV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 MQQTFNLFSTENSSAAWEQTLLEKFSIELFQQMNDLEACVIQEVGVEETPLMNEDSILAV 120
Qy 121 RKYFQRITLYLIERKYSPCAWEVVRAEIMRSLSFSTNLQKRLRRKD 166
||||||||||||||||||||||||||||||||||||||||||||||
Db 121 RKYFQRITLYLIERKYSPCAWEVVRAEIMRSLSFSTNLQKRLRRKD 166
Regarding the limitations of instant claim 5, Stimson teaches that the administration of the IFN-alpha14 can be topical or sublingual (see e.g. page 27, lines 5-15).
Regarding the limitations of instant claim 6, Stimson teaches that the administration can be at a dose that is dependent on a number of factors, and a broad range of doses is considered applicable (see e.g. page 29, lines 15-25). In particular the administration can comprise a “low” dose (see e.g. Example 2, page 33).
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.
1. Claims 1, 3, 5-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,487,127.
Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are directed to a method for the treatment and/or prophylaxis of pruritus, prurigo, neutrophilic dermatoses or skin cancer, said method comprising the step of: (i) administering to a subject in need thereof a therapeutically effective amount of an interferon alpha subtype, wherein the interferon alpha subtype is IFN-al4, HYBRID 1, HYBRID 2 or a combination of at least two of IFN-cd4, HYBRID 1 and HYBRID 2. Instant claim3 is directed to the method of claim 1, wherein the interferon alpha subtype HYBRID 1 comprises or consists of an amino acid sequence SEQ ID NO:2 or a functionally active fragment or variant thereof. Instant claim 5 is directed to the method of any preceding claim 1, wherein the method of administration is selected from topical administration and sublingual administration. Instant claim 6 is directed to the method of any preceding claim 1, wherein the therapeutically effective amount of the interferon alpha subtype is a low dose. Instant claim 8 is directed to the method of any preceding claim 1 for treatment of a condition selected from pruritus, prurigo, or neutrophilic dermatoses.
The reference patent teaches methods of treatment of a condition where enhancement of a Th1-mediated immune response and suppression of a Th2/Th17-mediated immune response are desired, and wherein the condition is cancer (see e.g. claim 1). The metho comprises administering an effective amount of a composition comprising IFN-alpha14 of SEQ ID NO:1 (see e.g. claim 1). The cancer can be skin cancer or melanoma (see e.g. claim 2). SEQ ID NO:1 from the reference patent is identical to SEQ ID NO:2 of the instant claims.
Furthermore, it is noted that the instant claims recite “prophylaxis” is not defined in the instant specification, but when given its general meaning, the term refers to action taken to prevent disease. To administer prophylactically requires that no disease is currently present during the administration. Therefore, the instant claims read on treatment of diseases like skin cancer and pruritus, but also on administering to any individual, including those that do not have those diseases, which will inherently prevent the disease upon administration. Administration in the reference patent would inherently provide this prevention function upon administration.
Instant claims 1, 3, and 8 are anticipated by the reference patent. However, the scope of the instant claims differs from the reference patent because the instant claim recites a broader range of diseases, and more possible IFN proteins for administration. Therefore the scope of the instant claims overlaps, but is not identical to the reference claims.
Regarding the limitations of claim 5 and 6, the reference claims recite oral administration (see e.g. reference claim 3).
It would have been obvious to one with ordinary skill in the art, at the time of the invention, that the administration could be sublingual and the administration could be optimized to minimize dosing because the Supreme Court set forth in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), that if the scope and content of the prior art included a similar or analogous product, with differences between the claimed invention and prior art that were encompassed in known variation or in a principle known in the art, and one of ordinary skill in the art could have combined the elements as claimed by known methods, the claimed variation would have been predictable in to one of ordinary skill in the art. The reference patent recites oral administration, but it would be obvious to one of skill in the art as a known variation or principle in the art, that various administration routes could be used to maximize compliance, uptake, and ease administration.
Furthermore, one of ordinary skilled in the art would have been motivated to optimize the dosing for the composition, since “it is the normal desire of scientists or artisans to improve upon what is already generally known”. The MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller. 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson. 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc, v. Biocraft Laboratories Inc.. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert, denied, 493 U.S. 975 (1989); In re Kulling. 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler. 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
2. Claims 1, 3, 5-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,267,860.
Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are directed to a method for the treatment and/or prophylaxis of pruritus, prurigo, neutrophilic dermatoses or skin cancer, said method comprising the step of: (i) administering to a subject in need thereof a therapeutically effective amount of an interferon alpha subtype, wherein the interferon alpha subtype is IFN-al4, HYBRID 1, HYBRID 2 or a combination of at least two of IFN-cd4, HYBRID 1 and HYBRID 2. Instant claim3 is directed to the method of claim 1, wherein the interferon alpha subtype HYBRID 1 comprises or consists of an amino acid sequence SEQ ID NO:2 or a functionally active fragment or variant thereof. Instant claim 5 is directed to the method of any preceding claim 1, wherein the method of administration is selected from topical administration and sublingual administration. Instant claim 6 is directed to the method of any preceding claim 1, wherein the therapeutically effective amount of the interferon alpha subtype is a low dose. Instant claim 8 is directed to the method of any preceding claim 1 for treatment of a condition selected from pruritus, prurigo, or neutrophilic dermatoses.
The reference patent teaches methods of treatment of a condition where enhancement of a Th1-mediated immune response and suppression of a Th2/Th17-mediated immune response are desired (see e.g. claim 1). The metho comprises administering an effective amount of a composition comprising IFN-alpha14 of SEQ ID NO:1 (see e.g. claim 1). The disorder can be cancer, allergy or an allergic disease (see e.g. claim 2). The cancer can be skin cancer (see e.g. claim 11). SEQ ID NO:1 from the reference patent is identical to SEQ ID NO:2 of the instant claims.
Furthermore, it is noted that the instant claims recite “prophylaxis” is not defined in the instant specification, but when given its general meaning, the term refers to action taken to prevent disease. To administer prophylactically requires that no disease is currently present during the administration. Therefore, the instant claims read on treatment of diseases like skin cancer and pruritus, but also on administering to any individual, including those that do not have those diseases, which will inherently prevent the disease upon administration. Administration in the reference patent would inherently provide this prevention function upon administration.
Instant claims 1, 3, and 8 are anticipated by the reference patent. However, the scope of the instant claims differs from the reference patent because the instant claims recite a different range of diseases, and more possible IFN proteins for administration. Therefore the scope of the instant claims overlaps, but is not identical to the reference claims.
It would have been obvious to one with ordinary skill in the art, at the time of the invention, that the administration could be sublingual and the administration could be optimized to minimize dosing because the Supreme Court set forth in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), that if the scope and content of the prior art included a similar or analogous product, with differences between the claimed invention and prior art that were encompassed in known variation or in a principle known in the art, and one of ordinary skill in the art could have combined the elements as claimed by known methods, the claimed variation would have been predictable in to one of ordinary skill in the art. The reference patent recites oral administration, but it would be obvious to one of skill in the art as a known variation or principle in the art, that various administration routes could be used to maximize compliance, uptake, and ease administration.
Furthermore, one of ordinary skilled in the art would have been motivated to optimize the dosing for the composition, since “it is the normal desire of scientists or artisans to improve upon what is already generally known”. The MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller. 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson. 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc, v. Biocraft Laboratories Inc.. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert, denied, 493 U.S. 975 (1989); In re Kulling. 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler. 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
3. Claims 1, 3, 5-6, and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 15-16, 18-19, 21, and 24-25 of copending Application No. 17/050,988 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The instant claims are directed to a method for the treatment and/or prophylaxis of pruritus, prurigo, neutrophilic dermatoses or skin cancer, said method comprising the step of: (i) administering to a subject in need thereof a therapeutically effective amount of an interferon alpha subtype, wherein the interferon alpha subtype is IFN-al4, HYBRID 1, HYBRID 2 or a combination of at least two of IFN-cd4, HYBRID 1 and HYBRID 2. Instant claim3 is directed to the method of claim 1, wherein the interferon alpha subtype HYBRID 1 comprises or consists of an amino acid sequence SEQ ID NO:2 or a functionally active fragment or variant thereof. Instant claim 5 is directed to the method of any preceding claim 1, wherein the method of administration is selected from topical administration and sublingual administration. Instant claim 6 is directed to the method of any preceding claim 1, wherein the therapeutically effective amount of the interferon alpha subtype is a low dose. Instant claim 8 is directed to the method of any preceding claim 1 for treatment of a condition selected from pruritus, prurigo, or neutrophilic dermatoses.
The reference application teaches methods of treatment and/or prophylaxis of psoriasis comprising administering an IFN-alpha14 protein that can comprise HYBRID 1, having SEQ ID NO:2 (see e.g. claim 1). The cancer can be skin cancer (see e.g. claim 11). SEQ ID NO:2 from the reference application is identical to SEQ ID NO:2 of the instant claims.
Furthermore, it is noted that the instant claims recite “prophylaxis” is not defined in the instant specification, but when given its general meaning, the term refers to action taken to prevent disease. To administer prophylactically requires that no disease is currently present during the administration. Therefore, the instant claims read on treatment of diseases like skin cancer and pruritus, but also on administering to any individual, including those that do not have those diseases, which will inherently prevent the disease upon administration. Administration in the reference application would inherently provide this prevention function upon administration.
Instant claims 1, 3, and 8 are anticipated by the reference application. However, the scope of the instant claims differs from the reference application because the instant claims recite a different range of diseases, and more possible IFN proteins for administration. Therefore the scope of the instant claims overlaps, but is not identical to the reference claims.
It would have been obvious to one with ordinary skill in the art, at the time of the invention, that the administration could be sublingual and the administration could be optimized to minimize dosing because the Supreme Court set forth in KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), that if the scope and content of the prior art included a similar or analogous product, with differences between the claimed invention and prior art that were encompassed in known variation or in a principle known in the art, and one of ordinary skill in the art could have combined the elements as claimed by known methods, the claimed variation would have been predictable in to one of ordinary skill in the art. The reference application recites oral and other types of administration, but it would be obvious to one of skill in the art as a known variation or principle in the art, that various administration routes could be used to maximize compliance, uptake, and ease administration.
Furthermore, one of ordinary skilled in the art would have been motivated to optimize the dosing for the composition, since “it is the normal desire of scientists or artisans to improve upon what is already generally known”. The MPEP states the following: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller. 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson. 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc, v. Biocraft Laboratories Inc.. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert, denied, 493 U.S. 975 (1989); In re Kulling. 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler. 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREA MCCOLLUM whose telephone number is (571)272-4002. The examiner can normally be reached 9:00 AM to 6:00 PM EST.
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, VANESSA FORD can be reached at (571)272-0857. 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.
/ANDREA K MCCOLLUM/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674