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 .
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.
DETAILED ACTION
This action is in response to claim amendments filed 11/14/24. Claims 1, 99-100, 111-115, 122-123, and 126-139 are pending and under examination.
Claim Objections
Claim 139 is objected to because of the following informalities: the list includes “protease inhibitor” and “proteinase inhibitor”. These are synonyms for the same genus and represent duplicate entries in the claim. Appropriate correction is required.
Claim 1 and 122 is objected to because of the following informalities: the claims recite “SEQ ID NO: 14”. SEQ ID NO: 14 does not contain a sequence in the sequence listing in compliance with ST.26 sequence rules. SEQ ID NO: 14 should be replaced with the actual sequence being referenced for unambiguous clarity. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 126, 131, 133, and 134 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
A humanized antibody is not part of the same chemical or art-recognized class as a monospecific/bispecific antibody. Further, they do not share a common use. Humanizing an antibody is used to e.g., lower immunogenicity (instant specification p. 54 L20-23) whereas specificity is used to define the target of the antibody (instant specification p. 60 L27).
Claim 131 is improper because portion (a) defines a wholly different structural aspect of the antibody as (b). Part (b) defines the heavy chain constant region, which doesn’t exist in, e.g., a Fab. Further, the two portions serve different uses. Fabs and scFVs are unique arrangements of the binding portion of the antibody to the antigen whereas the constant region relates to how the antibody is recognized by other ligands.
Claim 133 is improper because the alternatives do not share a common use. Alternative (a) defines the strength of binding to a particular antigen, in this case PD-1. Alternative (b) does not define any particular strength of binding but rather the position of binding on the PD-1 antigen. Alternative (c) is indefinite (see below) but appears to be directed to the use of binding multiple targets. Alternative (d) is not directed to the binding target at all, but to an enhancement property of the antibody.
Claim 134 is improper because alternative (a) defines the type of infection (acute, chronic, etc) while alternative (b) defines the cause of the infection, which is not an art recognized alternative to the disease itself.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claim 139 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 139 contains the trademark/trade name Civacir®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a limitation of the claim (the second therapeutic) by a trademark and, accordingly, the identification/description is indefinite.
Therefore, claim 139 is indefinite. Note that other tradenames are also used (e.g., Incivek) but these are accompanied by the generic name (e.g., telaprevir). These are considered defined by the generic terminology and not the tradename itself, instead including the tradenames as synonyms for the generic.
Claim 123 is 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 123 recites the limitation "the subject" in line 2. There is insufficient antecedent basis for this limitation in the claim. The claim does not set forth any subject prior to this recitation.
Further, the claim uses parentheticals to set out an “optionally” step. However, it is unclear how this is meant to define the scope of the claim. The parentheticals do not appear to have any specific purpose in the claim as they do not, e.g., define a synonym. If the parentheticals are meant to indicate that these are not claim limitations, then the question as to why the phrases exist in the first place is raised. See MPEP § 2173.05(d). If the parentheticals do not indicate that the phrases are not claim limitations, then it is unclear why the parentheticals are being used at all. Additionally, this line uses “or” twice as well as “and”. It is unclear if the parentheticals are being used to indicate that the “and optionally” only modifies “the subject” or if the “and” also modifies the first element of the list. Finally, where a “subject” is chosen, it is unclear if this qualifies as a method of detecting “in a biological sample” because the claim clearly makes a distinction between the two.
Therefore, claim 123 is indefinite.
Claim 132 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 132 requires a “serine to proline mutation at position 108 of SEQ ID NO: 212 or 214”. However, both SEQ 212 and 214 already have a proline at position 108. It is unclear how one could make a S108P mutation at this position when the position already has this residue. In one interpretation, the claim is meant to indicate that 212 and 214 already possess an S108P mutation as compared to some unclaimed parent sequence. In another, this is a typo and meant to be a P108S mutation to those sequences. The same rationale applies to the other sequences which appear to already be mutated at the relevant positions while the claim is directed to making those mutations in those sequences.
Claim 135 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 135 recites a list of causes of the infection. In alternative (b), the claim recites “meningococci and conococci”. First, conococci is not an art recognized bacteria. The instant specification only uses the term once (p.140), which is not accompanied by any definition nor indication as to what this genus is. Second, the use of “and” in the middle of a list makes it unclear if every name prior to this is a single element (syphilis, chlamydia…and conococci must all be simultaneously present), if the “and” only applies to the two names (meningococci and conococci must be simultaneously present), or if the “and” is meant to serve the same purpose as a comma.
Therefore, claim 135 is indefinite.
Claim 137 is 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.
The term “at risk” in claim 137 is a relative term which renders the claim indefinite. The term “at risk” 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. In the broadest sense, every subject with an immune system is “at risk” of being immunocompromised. The specification does not define “at risk” but provides examples such as “chemotherapeutic treatment” or “infection” (p.37 L10-14), suggesting there might be some level of risk that is not set forth by the claim or defined in the specification.
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 134, 137 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 134 sets forth two alternatives (a) and (b). Alternative (a) includes acute and chronic infections, which covers every possible type of infection, i.e., all infections are either acute or chronic. Alternative (b) is recited as “or” and so is not required. As such, the claim fails to place any further limitation on the claim from which it depends.
Claim 137 includes the subject being or at risk of being immunocompromised. The method is one of treating a subject with an antibody and so the subject must necessarily have an immune system themselves. Under the broadest, reasonable interpretation, any subject who could be treated by the instant method is either at some non-zero level of risk of being immunocompromised or else is already immunocompromised. As such, claim 137 does not provide any further limitation to the claims.
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.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 123 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 11827704. This is a statutory double patenting rejection.
Instant claim 123 depends from claim 1, which recites an identical scope for the antibody as found in reference claim 1. The preamble of claim 123 differs from reference claim 1 because ref claim 1 recites detection in a biological sample or subject whereas instant claim 123 only recites detection in a biological sample. However, the body of the instant claim includes detection in a subject and so the preamble does not differentiate the two claims. Further, while the instant claim includes “optional” steps, these optional steps are not required by the instant claim and are within the scope of the reference claim (“comprising”). The two claims appear to be coextensive and do not differ in scope.
The instant specification defines “isolated” as “material that is removed from its original or native environment” (specification p. 59). The instant specification also teaches that the claimed antibodies have been humanized, constructed, or otherwise obtained by various means (see e.g., Example 1). There does not appear to be an “original” or “native” environment for these antibodies as they are not naturally occurring and so appear to be “isolated” in all contexts of this definition. Since the antibodies are the same as those in the reference claims, the reference antibodies must also be isolated.
Claim 100 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 6 of prior U.S. Patent No. 10752687. This is a statutory double patenting rejection.
Reference claim 6 is a nucleic acid encoding one of four antibodies (reference claim 1), which is the same four antibodies of instant claim 1. Instant claim 100 is “an isolated nucleic acid” encoding these antibodies (same as reference claim) and is a single nucleic acid (“an”) so is the same as the heavy and light chains in the same nucleic acid molecule of reference claim 6. The two claims appear to be coextensive and do not differ in scope.
The instant specification defines “isolated” as “material that is removed from its original or native environment” (specification p. 59). The instant specification also teaches that the claimed antibodies have been humanized, constructed, or otherwise obtained by various means (see e.g., Example 1). There does not appear to be an “original” or “native” environment for these nucleic acids as they are not naturally occurring and so appear to be “isolated” in all contexts of this definition. Since the nucleic acids encoding these antibodies are the same as those in the reference claims, the reference nucleic acids must also be isolated.
Claims 1 and 99 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 29 of prior U.S. Patent No. 9815898. This is a statutory double patenting rejection.
Reference claim 1 claims the same antibody molecule with the same structure as the instant claims. The instant specification defines “isolated” as “material that is removed from its original or native environment” (specification p. 59). The instant specification also teaches that the claimed antibodies have been humanized, constructed, or otherwise obtained by various means (see e.g., Example 1). There does not appear to be an “original” or “native” environment for these molecules as they are not naturally occurring and so appear to be “isolated” in all contexts of this definition. Since the molecules are the same as those in the reference claims, the reference molecules must also be isolated.
Reference claim 29 and instant claim 99 recite the same limitations and depend from the independent claims, which are coextensive as above.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 100 and 111-113 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-90 of U.S. Patent No. 10752687. Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims and instant claims are nucleic acids encoding the same antibodies; see reference claim 1 and instant claim 1 claiming the same CDR combinations for the same antibodies. Instant claim 100 requires a single isolated nucleic acid encoding both chains of the antibody, which is the same as reference claim 6. The reference claim also claims expression vectors and host cells comprising these nucleic acids (e.g., reference claims 10 and 12) as well as the same method of producing the antibody (reference claim 14), rendering the instant claims an obvious variation of the previously patented claims.
The instant specification defines “isolated” as “material that is removed from its original or native environment” (specification p. 59). The instant specification also teaches that the claimed antibodies have been humanized, constructed, or otherwise obtained by various means (see e.g., Example 1). There does not appear to be an “original” or “native” environment for these nucleic acids as they are not naturally occurring and so appear to be “isolated” in all contexts of this definition. Since the nucleic acids encoding these antibodies are the same as those in the reference claims, the reference nucleic acids must also be isolated.
Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized ‘that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,’ but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’ The court pointed out that ‘this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.’’’ MPEP §804(II)(B)(1). In this case, the reference claims nucleic acids and explicitly teaches isolated nucleic acids (C53).
Claims 1, 99-100, 111-115, 122-123, 126-139 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-90 of U.S. Patent No. 10752687 in view of US20110271358 (form 892).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The relevance and teachings of the reference document are discussed above and incorporated herein. To the extent that isolating is considered not taught by the reference document, the reference document teaches nucleic acids that encode antibodies while ‘358 teaches isolating such molecules (e.g., claims 1, 19).
Reference claim 1 encodes an antibody molecule having a certain structure. This makes the structure of the antibody molecule anticipated/obvious and as such instant claim 1 is not patentably distinct from the reference document.
Regarding claim 99, the decisions in Sun Pharmaceuticals v Eli Lily Fed Cir July 28, 2010; Geneva v GlaxoSmithKline 349, F.3d 1373; and Pfizer v Teva 518 F3d 1353 support the Office’s use of disclosed utilities of compositions when applying double patenting rejections to method claims. The reference nucleic acids are used to encode antibodies and pharmaceutical compositions comprising the antibody (C2-3). ‘358 teaches PD-1 antibodies as pharmaceutical compositions with a carrier (e.g., claims 1 and 26). It would have been obvious to express the antibody of the reference document because this is the purpose disclosed for this composition in the reference and then combine it with a pharmaceutical carrier because this is a known preparation for a pharmaceutical antibody.
Regarding claim 114, ‘358 teaches administering the antibody to a subject suffering from an infection (e.g., claim 33). While ‘358 does not explicitly state that this administration stimulates the immune response, administering the same compound to the same person will necessarily achieve the same results. MPEP § 2112 (II) states, "there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)." Furthermore, Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) makes clear that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products. The reference document claims nucleic acids for expressing the antibody while ‘358 teaches one use of such an antibody is for administering as a treatment for infection. As such, the instant claim is not patentably distinct from the reference claim.
Regarding claim 115, as above, the reference document teaches nucleic acids for expressing an antibody. ‘358 teaches one use of such an antibody is for the treatment of cancer (e.g., claim 42). As such, the instant claim would have been obvious and is not patentably distinct.
Regarding claim 122, treating an infectious disease would have been obvious as above.
Regarding claim 123, the reference claims are directed to nucleic acids encoding an antibody as above. ‘358 teaches one use of such an antibody is for detecting PD-1 in a biological sample by contacting the sample with the antibody (e.g., paragraphs 37 and 191).
Regarding claim 126, claim 122 would have been obvious as above. The reference document claims the nucleic acid encodes an antibody with CDRs, which represent a binding fragment of an antibody. The use of “comprises an antigen binding fragment of an antibody” does not preclude this being an intact antibody because such antibodies “comprise” the binding fragment.
Regarding claim 127, the reference document claims the encoded antibody is bispecific and binds, e.g., PD-L1 (claim 5). ‘358 also teaches the antibody is bispecific and binds, e.g., PD-L1 (paragraph 138). It would have been obvious that the PD-1/PD-L1 bispecific antibody expressed by the nucleic acid of the reference document could be used in the same way as the PD-1/PD-L1 bispecific antibody ‘358 to treat infectious disease.
Regarding claims 128-130, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent as discussed above. In turning to the portions of the specification that support the antibody being encoded by the nucleic acid as claimed by the reference document, the same sequences in the same arrangement is disclosed.
Regarding claim 131 and 132, the reference document claims the antibody encoded by the nucleic acid comprises IgG1 and kappa with the same sequences (claims 40, 41).
Regarding claim 133, the reference document claims nucleic acids expressing the same antibody as instantly claimed. As such, the properties of that antibody must also be the same.
Regarding claims 134-135, treatment of infectious disease would have been obvious as above. ‘358 teaches the infection to be treated is bacterial (claim 36), specifically chlamydia (claim 37).
Regarding claim 136, treatment of infectious disease would have been obvious as above. ‘358 teaches the infection to be treated is hepatitis B (claim 35).
Regarding claim 137, treatment of infectious disease would have been obvious as above. All subjects are at some degree of risk for being immunocompromised and so the reference combination necessarily meets this limitation.
Regarding claims 138 and 139, treatment of infectious disease would have been obvious as above. ‘358 teaches combining these therapeutic antibodies with a vaccine (e.g., paragraph 287).
Claims 1, 99-100, 111-115, 122-123, 126-139 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9815898 in view of US20110271358.
These claims are coextensive as discussed above. In the case that “isolated” represents a sufficient distinction, this would nevertheless have been an obvious variation as the reference document defines “antibody molecule” as including “isolated” (C3; C23).
The relevance and teachings of the reference document are discussed above and incorporated herein. To the extent that isolating is argued as not taught by the reference document, the reference document teaches antibodies while ‘358 teaches isolating such molecules (e.g., claims 1).
Reference claim 1 is an antibody molecule having a certain structure. This makes the structure of the antibody molecule anticipated/obvious and as such instant claim 1 is not patentably distinct from the reference document.
Regarding claim 99, the reference document teaches including a carrier with the antibody (claim 29).
Regarding claims 100 and 111-112, the reference document claims the antibody but not a nucleic acid encoding the antibody. However, this is an obvious variation as ‘358 teaches encoding antibodies in nucleic acids (claim 20) as well as in expression vectors (claim 21; paragraph 21) and host cells (claim 22; paragraph 85).
Regarding claim 113, the reference document claims the antibody but not a method of producing the antibody comprising the host cell. However, this is an obvious variation as ‘358 teaches this method (e.g., claim 23; paragraph 85).
Regarding claims 114-115, 122, 123, The decisions in Sun Pharmaceuticals v Eli Lily Fed Cir July 28, 2010; Geneva v GlaxoSmithKline 349, F.3d 1373; and Pfizer v Teva 518 F3d 1353 support the Office’s use of disclosed utilities of compositions when applying double patenting rejections to method claims. The reference claims are to a composition: the antibody. Disclosed in the reference document are the identical methods of use instantly claimed.
Additionally, regarding claim 114, ‘358 teaches administering the antibody to a subject suffering from an infection (e.g., claim 33). While ‘358 does not explicitly state that this administration stimulates the immune response, administering the same compound to the same person will necessarily achieve the same results. MPEP § 2112 (II) states, "there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)." Furthermore, Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) makes clear that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products. The reference document claims the antibody while ‘358 teaches one use of such an antibody is for administering as a treatment for infection. As such, the instant claim is not patentably distinct from the reference claim.
Regarding claim 115, as above, the reference document claims an antibody. ‘358 teaches one use of such an antibody is for the treatment of cancer (e.g., claim 42). As such, the instant claim would have been obvious and is not patentably distinct.
Regarding claim 122, treating an infectious disease would have been obvious as above.
Regarding claim 123, the reference claims are directed to an antibody as above. ‘358 teaches one use of such an antibody is for detecting PD-1 in a biological sample by contacting the sample with the antibody (e.g., paragraphs 37 and 191).
Regarding claim 126, the reference document claims the antibody is humanized (claim 6), making this an obvious variation. Further, the claimed antibody of the reference comprises CDRs, which are an antigen binding fragment of an antibody.
Regarding claim 127, the reference document claims the antibody is bispecific and also binds PD-L1 (claim 26), making this an obvious variation. ‘358 also teaches the antibody is bispecific and binds, e.g., PD-L1 (paragraph 138). It would have been obvious that the PD-1/PD-L1 bispecific antibody of the reference document could be used in the same way as the PD-1/PD-L1 bispecific antibody ‘358 to treat infectious disease.
Regarding claims 128-130, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent as discussed above. In turning to the portions of the specification that support the claimed antibody, the same sequences in the same arrangement is disclosed in the reference.
Regarding claim 131 and 132, the reference document claims the antibody comprises IgG1 and kappa with the same sequences (claims 17, 18).
Regarding claim 133, the reference document claims the same antibody as instantly claimed. As such, the properties of that antibody must also be the same. Further, the reference document claims the same KD (claim 19).
Regarding claims 134-135, treatment of infectious disease would have been obvious as above. ‘358 teaches the infection to be treated is bacterial (claim 36), specifically chlamydia (claim 37).
Regarding claim 136, treatment of infectious disease would have been obvious as above. ‘358 teaches the infection to be treated is hepatitis B (claim 35).
Regarding claim 137, treatment of infectious disease would have been obvious as above. All subjects are at some degree of risk for being immunocompromised and so the reference combination necessarily meets this limitation.
Regarding claims 138 and 139, treatment of infectious disease would have been obvious as above. ‘358 teaches combining these therapeutic antibodies with a vaccine (e.g., paragraph 287).
Claims 1, 99-100, 111-115, 122-123, 126-139 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of prior U.S. Patent No. 11827704 in view of US20110271358.
These claims are coextensive as discussed above. In the case that “isolated” represents a sufficient distinction, this would nevertheless have been an obvious variation as the reference document defines “antibody molecule” as including “isolated” (C3; C23).
The relevance and teachings of the reference document are discussed above and incorporated herein. To the extent that isolating is argued as not taught by the reference document, the reference document teaches using antibodies while ‘358 teaches isolating such molecules for use (e.g., claims 1, 33, 52, 53).
Reference claim 1 is a method of detecting PD-1 in a biological sample comprising contacting the sample with an antibody molecule having a certain structure. This structure is identical to the instantly claimed antibody. This makes the structure of the antibody molecule anticipated/obvious and as such instant claim 1 is not patentably distinct from the reference document.
Regarding claim 99, ‘358 teaches PD-1 antibodies as pharmaceutical compositions with a carrier (e.g., claims 1 and 26). It would have been obvious to combine the antibody used in the reference method with a carrier because this is a known preparation for a pharmaceutical antibody for such a use.
Regarding claims 100 and 111-112, the reference document claims a method of using the antibody but not a nucleic acid encoding the antibody. However, this is an obvious variation as ‘358 teaches encoding antibodies in nucleic acids (claim 20) as well as in expression vectors (claim 21; paragraph 21) and host cells (claim 22; paragraph 85).
Regarding claim 113, the reference document claims the antibody in a method of use but not a method of producing the antibody comprising the host cell. However, this is an obvious variation as ‘358 teaches this method (e.g., claim 23; paragraph 85).
Regarding claim 114, the reference document claims a method of detecting PD-1 with a PD-1 antibody. ‘358 teaches administering a PD-1 antibody to a subject suffering from an infection (e.g., claim 33). While ‘358 does not explicitly state that this administration stimulates the immune response, administering the same compound to the same person will necessarily achieve the same results. MPEP § 2112 (II) states, "there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)." Furthermore, Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) makes clear that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products. The reference document claims a method of using the antibody while ‘358 teaches another predictable use of such an antibody is for administering as a treatment for infection. As such, the instant claim is not patentably distinct from the reference claim.
Regarding claim 115, as above, the reference document claims a method of using an antibody. ‘358 teaches another predictable use of such an antibody is for the treatment of cancer (e.g., claim 42). As such, the instant claim would have been obvious and is not patentably distinct.
Regarding claim 122, treating an infectious disease would have been obvious as above.
Regarding claim 123, the reference claims are directed to the same method (claim 1). ‘358 also teaches one use of such an antibody is for detecting PD-1 in a biological sample by contacting the sample with the antibody (e.g., paragraphs 37 and 191).
Regarding claim 126, the reference document claims the antibody is humanized (claim 31), making this an obvious variation. Further, the claimed antibody of the reference comprises CDRs, which are an antigen binding fragment of an antibody.
Regarding claim 127, the reference document does not claim the antibody used is bispecific. However, ‘358 teaches a PD-1 antibody which is bispecific and binds, e.g., PD-L1 (paragraph 138). It would have been obvious that the PD-1 specific antibody of the reference document could be modified and used in the same way as the PD-1/PD-L1 bispecific antibody ‘358 to treat infectious disease.
Regarding claims 128, the reference document claims the antibody with the same sequences in the same arrangement (claims 32 and 33).
Regarding claim 129, the reference document claims the antibody with the same sequences (claims 34 and 35).
Regarding claim 130, the reference document claims the antibody with the same sequences (claims 36 and 37).
Regarding claim 131 and 132, the reference document claims the antibody comprises IgG1 and kappa with the same sequences (claims 42, 43).
Regarding claim 133, the reference document claims a method using the same antibody as instantly claimed. As such, the properties of that antibody must also be the same.
Regarding claims 134-135, treatment of infectious disease would have been obvious as above. ‘358 teaches the infection to be treated is bacterial (claim 36), specifically chlamydia (claim 37).
Regarding claim 136, treatment of infectious disease would have been obvious as above. ‘358 teaches the infection to be treated is hepatitis B (claim 35).
Regarding claim 137, treatment of infectious disease would have been obvious as above. All subjects are at some degree of risk for being immunocompromised and so the reference combination necessarily meets this limitation.
Regarding claims 138 and 139, treatment of infectious disease would have been obvious as above. ‘358 teaches combining these therapeutic antibodies with a vaccine (e.g., paragraph 287).
Claims 1, 99-100, 111-115, 122-123, 126-139 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-144 of prior U.S. Patent No. 9683048 in view of US20110271358.
Instant claim 114 is a method of stimulating an immune response in a subject by administering one of four antibodies. Reference claims 1-4 are individually one of these four same antibodies in the same method.
Instant claim 115 is a method of treating cancer in a subject by administering one of four antibodies. Reference claims 6-9 are individually one of these four same antibodies in the same method.
These claims are coextensive as discussed above. In the case that “isolated” represents a sufficient distinction, this would nevertheless have been an obvious variation as the reference document defines “antibody molecule” as including “isolated” (C3; C23).
The relevance and teachings of the reference document are discussed above and incorporated herein. To the extent that isolating is argued as not taught by the reference document, the reference document teaches using antibodies while ‘358 teaches isolating such molecules for use (e.g., claims 1, 33, 52, 53).
Reference claim 1 is a method of stimulating an immune response comprising contacting the sample with an antibody molecule having a certain structure. Reference claim 6 is a method of treating cancer using the same antibodies. This structure is identical to the instantly claimed antibody. This makes the structure of the antibody molecule anticipated/obvious and as such instant claim 1 is not patentably distinct from the reference document.
Regarding claim 99, ‘358 teaches PD-1 antibodies as pharmaceutical compositions with a carrier (e.g., claims 1 and 26). It would have been obvious to combine the antibody used in the reference method with a carrier because this is a known preparation for a pharmaceutical antibody for such a use.
Regarding claims 100 and 111-112, the reference document claims a method of using the antibody but not a nucleic acid encoding the antibody. However, this is an obvious variation as ‘358 teaches encoding antibodies in nucleic acids (claim 20) as well as in expression vectors (claim 21; paragraph 21) and host cells (claim 22; paragraph 85).
Regarding claim 113, the reference document claims the antibody in a method of use but not a method of producing the antibody comprising the host cell. However, this is an obvious variation as ‘358 teaches this method (e.g., claim 23; paragraph 85).
Regarding claim 114, this claim is discussed above. Fruther, ‘358 teaches administering a PD-1 antibody to a subject suffering from an infection (e.g., claim 33). While ‘358 does not explicitly state that this administration stimulates the immune response, administering the same compound to the same person will necessarily achieve the same results. MPEP § 2112 (II) states, "there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003)." Furthermore, Integra Life Sciences I Ltd. v. Merck KGaA, 50 USPQ2d 1846 (DC SCalif, 1999) makes clear that a reference teaching a process may anticipate claims drawn to a method comprising the same process steps, despite the recitation of a different intended use in the preamble or the later discovery of a particular property of one of the starting materials or end products. The reference document claims a method of stimulating the immune response with the antibody while ‘358 teaches another predictable use of such an antibody is for administering as a treatment for infection. As such, the instant claim is not patentably distinct from the reference claim.
Regarding claim 115, as above, the reference document claims a method of treating cancer with the antibody. ‘358 also teaches treatment of cancer with a PD-1 antibody (e.g., claim 42). As such, the instant claim would have been obvious and is not patentably distinct.
Regarding claim 122, treating an infectious disease would have been obvious as above.
Regarding claim 123, the reference claims do not claim detecting PD-1. ‘358 teaches one use of such a PD-1 antibody is for detecting PD-1 in a biological sample by contacting the sample with the antibody (e.g., paragraphs 37 and 191).
Regarding claim 126, the reference document claims the antibody is humanized (claim 73), making this an obvious variation. Further, the claimed antibody of the reference comprises CDRs, which are an antigen binding fragment of an antibody.
Regarding claim 127, the reference document claims the antibody is bispecific and also binds PD-L1 (claim 5), making this an obvious variation. ‘358 also teaches the antibody is bispecific and binds, e.g., PD-L1 (paragraph 138). It would have been obvious that the PD-1/PD-L1 bispecific antibody the reference document could be used in the same way as the PD-1/PD-L1 bispecific antibody ‘358 to treat infectious disease.
Regarding claims 128, the reference document claims the antibody with the same sequences in the same arrangement (claims 74 and 75).
Regarding claim 129, the reference document claims the antibody with the same sequences (claims 76 and 77).
Regarding claim 130, the reference document claims the antibody with the same sequences (claims 78 and 79).
Regarding claim 131 and 132, the reference document claims the antibody comprises IgG1 and kappa with the same sequences (claims 84, 85).
Regarding claim 133, the reference document claims the same properties of the antibody (claim 86).
Regarding claims 134-135, treatment of infectious disease would have been obvious as above. ‘358 teaches the infection to be treated is bacterial (claim 36), specifically chlamydia (claim 37).
Regarding claim 136, treatment of infectious disease would have been obvious as above. ‘358 teaches the infection to be treated is hepatitis B (claim 35).
Regarding claim 137, treatment of infectious disease would have been obvious as above. All subjects are at some degree of risk for being immunocompromised and so the reference combination necessarily meets this limitation.
Regarding claims 138 and 139, treatment of infectious disease would have been obvious as above. ‘358 teaches combining these therapeutic antibodies with a vaccine (e.g., paragraph 287).
Allowable Subject Matter
Claim 136 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding the independent claims, the antibody is claimed by a combination of six CDRs. The CDRs are known to define the specificity of an antibody and are also well-known to be unpredictable when mutated. Single amino acid changes can alter the binding specificity of an antibody to increase binding, decrease binding, abrogate binding, or change the target of binding entirely. The claimed combinations were not found in the prior art. Further, without clear guidance to arrive at these combinations, the unpredictability of altering CDRs supports a conclusion of non-obviousness.
Conclusion
It is recognized that the instant application was filed as a divisional. 35 USC 121 describes certain protections for divisional applications when the claims are filed as a result of a restriction and commensurate with the restriction. First, the instant claims contain claims to all five groups originally set forth in the restriction and so there would be no protection from instant claims belonging to e.g., original group 1 against a patent also containing claims to original group 1. Second, 35 USC 121 states: “A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application.” In this case, the instant application was filed 5/31/24, which is after the issuance of the patents used in the double patenting rejections above. As such, there is no 121 protection against these patents.
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/Adam Weidner/Primary Examiner, Art Unit 1675
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