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 .
Detailed Action
Claims 1-10 are pending in this application and is now under consideration for examination.
Priority
Applicants’ claim for the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a CON of 17/199,484 filed on 03/12/2021 now US 12104186, which is a CON of 16/432,246 filed on 06/05/2019 now US 11091749, which is a CON of 15/310,917 filed on 11/14/2016 now US 10358636, which is a 371 of PCT/US2015/030765 filed on 05/14/2015 which claims benefit of Provisional application 62/155,079 filed on 04/30/2015 and claims benefit of Provisional application 62/115,326 filed on 02/12/2015 and claims benefit of Provisional application 62/003,256 filed on 05/27/2014 and claims benefit of Provisional application 61/993,056 filed on 05/14/2014. Please note regarding recited substitutions “Ile99, Lys95, Tyr93, Leu83, Lys46, Ile41, Asn13, or Asn12 of SEQ ID NO:49” in claim 1, the granted priority date is Provisional application 62/003,256 filed on 05/27/2014.
Information disclosure statement
The information disclosure statement (IDS) submitted on 07/30/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
Claim Rejections: 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(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 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claim 1 and dependent claims 2-10 thereof encompass the limitation: A deimmunized lysostaphin “comprising” a mutation at one or more of….SEQ ID NO: 49.
The limitation “comprising” in this independent claim 1 broadly encompasses any additional mutation other than the recited “Ser124, Ser122, Asn121, Arg118, Ile99, Lys95, Tyr93, Leu83, Lys46, Ile41, Asn13, or Asn12 of SEQ ID NO:49” mutations. In essence the protein can have any number of mutations of its structure mutated and having any undefined sequence identity to SEQ ID NO: 49 in addition to one or more of the recited residues/mutations encompassed in the claims (as in claims 1-7); and method for treating or preventing a microbial infection… comprising said polypeptides (as in claims 8-10).
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus.”). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the biomolecule, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed biomolecule.”
“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 function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” MPEP 2163.
Furthermore, 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 the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure ‘indicates that the patentee has invented species sufficient to constitute the gen[us].’ See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (‘[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.’). ‘A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.’ In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).” MPEP 2163.
Factors to be considered in making the determination as to whether one skilled in the art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include: a. Actual reduction to practice; b. Disclosure of drawings or structural chemical formulas; c. Sufficient relevant identifying characteristics such as i. Complete structure, ii. Partial structure, iii. Physical and/or chemical properties or iv. Functional characteristics when coupled with a known or disclosed correlation between function and structure; d. Method of making the claimed invention; e. Level of skill and knowledge in the art and f. Predictability in the art. While all of these factors are considered, a sufficient number for a prima facie case are discussed as they relate to the issues mentioned above.
The specification does not teach lysostaphin variants with 10%, 20%, 30%, 40%...80% or more changes relative to lysostaphin sequence of SEQ ID NO: 49 having any undefined sequence identity to SEQ ID NO: 49 that retain activity.
"[T]he 'essential goal' of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to put the public in possession of what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998).”
The claims are directed to a genus of lysostaphin sequences that are variants of SEQ ID NO: 49 that retain a desired activity. However the specification only discloses the reduction into practice of the amino acid sequence of SEQ ID NO: 49 and specific variants at positions “Ser124, Ser122, Asn121, Arg118, Ile99, Lys95, Tyr93, Leu83, Lys46, Ile41, Asn13, or Asn12 of SEQ ID NO: 49” that retain variable levels of activity.
Applicants have not reduced into practice the claimed genus of de-immunized lysostaphin having any structure, or that encode lysostaphin that can have up 10%, 20%, 30%, 40%...80% or more changes relative to lysostaphin sequence of SEQ ID NO: 49 having any undefined sequence identity to SEQ ID NO: 49 that retain activity.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V.v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, lnc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997).
The level of skill in the art is such that one of skill would not be able to identify without further testing which of the genus of variant discussed above that retain activity. Based on the lack of knowledge and predictability in the art, those skilled in the art would not conclude that applicants was in possession of the claimed genus of proteins based on disclosure of specific limited variants of the lysostaphin of SEQ ID NO: 49.
Therefore, one skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed. Applicants are referred to the revised guidelines concerning compliance with the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Enablement
Claims 8-10 (depending from claims 5 and 1) are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for an isolated polypeptide of SEQ ID NO: 49 and the recited specific variants of SEQ ID NO: 49 and having lysostaphin activity and method of using said polypeptide for treating a microbial infection, does not reasonably provide enablement for any deimmunized lysostaphin “comprising” a mutation at one or more of….SEQ ID NO: 49 of undefined sequence identity to SEQ ID NO: 49 in addition to one or more of the recited residues encompassed in the claims (as in claims 1-7); and method for treating or preventing a microbial infection… comprising said polypeptides (as in claims 8-10). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims without undue experimentation.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988) as follows: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claim(s).
Claims 8-10 (depending from claims 5 and 1), broadly encompass any deimmunized lysostaphin “comprising” a mutation at one or more of….SEQ ID NO: 49 of undefined sequence identity to SEQ ID NO: 49 in addition to one or more of the recited residues encompassed in the claims (as in claims 1-7); and method for treating or preventing a microbial infection… comprising said polypeptides (as in claims 8-10) irrespective of etiology and pathology. The scope of the claims does not commensurate with the enablement provided by the disclosure with regard to: i) any or all lysostaphins with wide variety of structures from any source; and ii) in the use of said lysostaphins in preventing or treating of any microbial infection irrespective of etiology and pathology, that are broadly encompassed by the claims. The disclosure is limited to an isolated polypeptide of SEQ ID NO: 49 and the recited specific variants of SEQ ID NO: 49 and having lysostaphin activity and method of using said polypeptide for treating a microbial infection. However, the specification is silent on: i) any or all lysostaphins with wide variety of structures from any source; and ii) in the use of said lysostaphins in preventing or treating of any microbial infection irrespective of etiology and pathology in real-world medical situations as the specification provides no specific steps or guidance of preparing said lysostaphin for administration to a patient in prevention or treatment of any microbial infection and specific route of administration including dosage. Therefore, it would require undue experimentation by the skilled artisan to make and use the claimed composition for: i) any or all lysostaphins with wide variety of structures from any source; and ii) in the use of said lysostaphins in preventing or treating of any microbial infection irrespective of etiology and pathology in real-world medical situations.
In view of the great breadth of the claims, amount of experimentation required to make and use the claimed composition, the lack of guidance, working examples, and unpredictability of the art in predicting the use of either the polypeptide composition described in the present invention or any lysostaphin composition in the prevention or treating of any microbial infection irrespective of etiology and pathology in real-world medical situations. For the above purpose, the claimed invention would require undue experimentation. As such, the specification fails to teach one of ordinary skill how to use the full scope of the composition encompassed by the claims.
Thus, applicants have not provided sufficient guidance or shown any therapeutic procedures in their working examples to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims broadly including: any or all lysostaphins with wide variety of structures from any source; and in the use of said lysostaphins in preventing or treating of any microbial infection irrespective of etiology and pathology, that are broadly encompassed by the claims. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 1924 (CCPA 1970)). Without sufficient guidance, determination of compositions for making and using said polypeptide compositions is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly extensive and undue. See In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988).
Claim Rejections: 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title
Claims 1 and 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1 and 4 are directed to a law of nature or a natural phenomenon. Claims 1 and 4 as interpreted are directed to a genus of lysostaphin polypeptides and having associated function, said genera of polypeptides having any sequence identity to SEQ ID NO: 49 of undefined and unlimited structures and “comprising” “Ser124, Ser122, Asn121, Arg118, Ile99, Lys95, Tyr93, Leu83, Lys46, Ile41, Asn13, or Asn12 of SEQ ID NO: 49” s (also see 35 U.S.C. 112(a) rejections above for claims interpretation).The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons stated below.
The “2014 Interim Guidance on Patent Subject Matter Eligibility” 79 FR 74618 (Dec. 16, 2014) directs that claims drawn to 1) a composition of matter, 2) a law of nature or a natural phenomenon and 3) lacking recitation of additional elements that make the claims directed to significantly more than a judicial exception are ineligible for patenting under 35 U.S.C. 101. See, 79 FR, page 74621 (flow chart). Nature-based compositions of matter are not directed to significantly more than a judicial exception when the claimed "naturally occurring products and some man-made products ... are essentially no different from a naturally occurring product ... that fall under the laws of nature or natural phenomena exception.” 79 FR, page 74623, left column. That is, a patent-eligible composition of matter must be "markedly different" in terms of the "product's structure, function, and/or other properties." 79 FR, page 74623, center column. Further, processes directly to isolating nature-based compositions of matter have also been found to be directed to nothing more than a judicial exception when only routine purification techniques are employed. 79 FR, page 74622, center column (e.g. isolating DNA or other nature-based products).
Here, naturally-occurring variant polypeptides having Glycyl-glycine endopeptidase/lysostaphin activity are disclosed, said reference polypeptides having a sequence identity of at least 83.5% and 78.2% to SEQ ID NO: 49 the instant application is disclosed by the following references: (i) UniProtKB/TrEMBL Accesion#O05156, Fujiwara et al., disclose a variant Glycyl-glycine endopeptidase/lysostaphin and having 83.5% sequence identity to SEQ ID NO: 49 and having the following substitutions I41V, K46A and Y93R; and (ii) UniProtKB/TrEMBL Accesion#A0ABQ1HPK1, Wu et al., disclose a variant Glycyl-glycine endopeptidase/lysostaphin and having 78.2% sequence identity to SEQ ID NO: 49 and having the following substitutions N12T, N13Q, K46A, Y93V and S112N (see provided sequence alignments). The features of claims 1 and 4 are met by the reference polypeptides in the disclosed references above. Since the features of the claim 1 and 4 are met by the structure of mutant polypeptide SEQ ID NO: 49 of the instant invention and the claims do not recite additional features or elements that amount to significantly more than the judicial exception, since the structure recited in claims 1 and 4 is "essentially no different from a naturally occurring product” such that there is no marked difference in the "product's structure, function, and/or other properties. As such, the claims 1 and 4 recite patent ineligible subject matter for the reasons stated; examiner also takes the position that structure and function are inseparable and the cited reference polypeptides have inherently all the biochemical/biological functions as recited in claims 1 and 4.
Claim Rejections: 35 USC § 102 (AIA )
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.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Fujiwara et al., (J. Bacteriol., 2005, Vol. 187: 480-487) disclose a variant Glycyl-glycine endopeptidase/lysostaphin and having 83.5% sequence identity to SEQ ID NO: 49 and having the following substitutions I41V, K46A and Y93R; UniProtKB/TrEMBL Accesion#O05156, see provided sequence alignment). Said variant also has at least one of the structural limitation recited in each of claims 1and 4; examiner also takes the position that structure and function are inseparable and the cited reference polypeptides have inherently all the biochemical/biological functions as recited in claims 1 and 4.
Therefore, claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Fujiwara et al., (J. Bacteriol., 2005, Vol. 187: 480-487) as written and when given the broadest reasonable interpretation
Claim Rejections: 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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
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 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.
Claims 1-2 and 3-10 are rejected under 35 U.S.C. 103(a) as being unpatentable over Fujiwara et al., (J. Bacteriol., 2005, Vol. 187: 480-487) as applied to claims 1 and 4 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and in view of Griswold et al., (US 11,155,801 B2; priority 08/06/2013) and Climo et al., (US 6,569,830 B1).
The disclosure of Fujiwara et al., (J. Bacteriol., 2005, Vol. 187: 480-487) as applied to claims 1 and 4 is described above in 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above. However, Fujiwara et al., is silent regarding wherein said lysostaphin is aglycosylated (as in claim 2); …pharmaceutical composition comprising the deimmunized lysostaphin (as in claims 5-7); and a method of preventing or treating of any microbial infection (as in claims 8-10; also see 35 U.S.C. 112(a) rejections above for claims interpretation).
Regarding claims 2 and 5-10, the following reference teaches the structural and functional elements of the instant invention and methods of use: Griswold et al., (US 11,155,801 B2; priority 08/06/2013).
Griswold et al., (US 11,155,801 B2; priority 08/06/2013) discloses variants of the lysostaphin of SEQ ID NO: 49 therein (reference polypeptide having 100% identity with SEQ ID NO: 49 of the instant invention; see provided sequence alignments), said variants having any amino acid at the position corresponding to one or more of the i.e., as well as a method for production of unglycosylated lysostaphin variant protein and have been shown to have activity equivalent to wild-type lysostaphin; the lysostaphin variant proteins can be used as therapeutic proteins for treatment of diseases such as Staphylococcus aureus infection (see Abstract; Fig. 1-2 and entire document); and provide teaching, suggestion and motivation for pharmaceutical compositions comprising said reference unglycosylated lysostaphin and antibiotics “It is also contemplated that the LST variant protein can be used either alone or in combination with other agents commonly used to treat bacterial infections in patients. Such agents would include but not be limited to any of the known and marketed antibiotics” (see col. 10, lines 39-43; col. 11, lines 35-67 to col. 12, lines 1-65).
Regarding claims 8-10 Climo et al., (US 6,569,830 B1), also teach administration of a pharmaceutical composition effective in the treatment of staphylococcal infection, said reference composition comprises at least two active agents, one an agent like lysostaphin which cleaves the glycine-containing cross-links of the cell wall peptidoglycans of staphylococci, the other a cell-wall active antibiotic; including lysostaphin wild type, a mutant or variant, or any recombinant or related enzyme that retains proteolytic activity against glycine-containing cross-links in the cell wall peptidoglycan of staphylococci in combination with the cell-wall active antibiotic is a .beta-lactam antibiotic and glycopeptides (Abstract; col. 3, lines 7-67 to col. 5, lines 1-10).
As such, disclosure of polypeptides and variants of the lysostaphin of SEQ ID NO: 49 therein (having 100%- 83.5% identity with SEQ ID NO: 49 of the instant invention), as well as a method for production of unglycosylated lysostaphin variant proteins and have been shown to have activity equivalent to wild-type lysostaphin; suggesting the reference lysostaphin variant proteins can be used as therapeutic proteins for treatment of diseases such as Staphylococcus aureus infection, clearly suggests to a skilled artisan to modify the teachings of Fujiwara et al., i.e., specific combinable mutations and the biochemical advantages of the claimed combination of substitutions as claimed in claims 1-2 and 4-10 of the instant invention and in combination with pharmaceutical compositions comprising antibiotic in the cited secondary references and as claimed in the instant invention; for details see the rejection above.
Therefore, it would have been obvious to a person of ordinary skill in the art to combine and modify the teachings of Fujiwara et al., and employ the reference variant lysostaphin polypeptide of Fujiwara et al., in a pharmaceutical compositions and methods of use, as disclosed in the references of Griswold et al., and Climo et al. Motivation to generate such a pharmaceutical composition comprising the variant/mutant lysostaphin derives from the fact that such pharmaceutical compositions are commercial product of importance (Griswold et al., and Climo et al.,). The expectation of success is high, because the combined teachings of Fujiwara et al., Griswold et al., and Climo et al., teach the structural and functional elements of the instant invention including pharmaceutical compositions comprising lysostaphin, antibiotics and method of use (Teaching, Suggestion and Motivation).
Therefore, claims 1-2 and 3-10 are rejected under 35 U.S.C. 103(a) as being unpatentable over Fujiwara et al., (J. Bacteriol., 2005, Vol. 187: 480-487) as applied to claims 1 and 4 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and in view of Griswold et al., (US 11,155,801 B2; priority 08/06/2013) and Climo et al., (US 6,569,830 B1).
Double Patenting rejection
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-10 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over allowed patents: (i) Claims 1-16 and 19-34 of Griswold et al., (US 10,358,636); (ii) Claims 1-17, 19-24 and 26-29 of Griswold et al., (US 11,091,749); and (iii) Claims 8-10 (depending from claim 5 and 1) of the instant invention over claims 1-21 of Griswold et al., (US 12,104,186). An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claims are not patentably distinct from the reference claims, because the examined claims are either anticipated by, or would have been obvious over reference claims. 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).
Although the conflicting claims are not identical, they are not patentably distinct from each other. Claims 1-10 of the instant application cannot be considered patentably distinct over allowed patents: (i) Claims 1-16 and 19-34 of Griswold et al., (US 10,358,636); (ii) Claims 1-17, 19-24 and 26-29 of Griswold et al., (US 11,091,749); and (iii) Claims 8-10 (depending from claim 5 and 1) of the instant invention over claims 1-21 of Griswold et al., (US 12,104,186), when there is specifically disclosed embodiments and falls within the scope of the claims 1-10 herein i.e., claims 1-10 of the instant invention as interpreted are directed to any deimmunized lysostaphin “comprising” a mutation at one or more of….SEQ ID NO: 49 of undefined sequence identity to SEQ ID NO: 49 in addition to one or more of the recited residues encompassed in the claims (as in claims 1-7); and method for treating or preventing a microbial infection… comprising said polypeptides (as in claims 8-10). In the instant case, the allowed patent specifications and allowed patents: (i) Claims 1-16 and 19-34 of Griswold et al., (US 10,358,636); (ii) Claims 1-17, 19-24 and 26-29 of Griswold et al., (US 11,091,749); and (iii) Claims 1-21 of Griswold et al., (US 12,104,186) discloses as a preferred embodiment and reproduced below: said reference polypeptides have 100% sequence identity to SEQ ID NO: 49 of the instant invention including the recited specific mutants of the instant invention.
ODP: US 10,358,636
PNG
media_image1.png
404
532
media_image1.png
Greyscale
ODP: US 12,104,186
PNG
media_image2.png
406
538
media_image2.png
Greyscale
Therefore, claims 1-10 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over allowed patents: (i) Claims 1-16 and 19-34 of Griswold et al., (US 10,358,636); (ii) Claims 1-17, 19-24 and 26-29 of Griswold et al., (US 11,091,749); and (iii) Claims 8-10 (depending from claim 5 and 1) of the instant invention over claims 1-21 of Griswold et al., (US 12,104,186).
Allowable Subject Matter
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHIRAMA RAGHU whose telephone number is (571)272-4533. The examiner can normally be reached on M-F 8:30am-5pm 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, Robert Mondesi can be reached on 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
