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 .
Applicants are advised that the Examiner of Record has changed.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-20 in the reply filed on November 20, 2024 is acknowledged.
Claims 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 20, 2024.
Priority
The present application is a CON of 16/948,987 filed on 10/08/2020 and also claims the benefit under 35 U.S.C 119 (e) to U.S. Provisional Application No. 63/024,218 filed 05/13/2020 and to U.S. Provisional Application No. 62/912,439filed 10/08/2019. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C 119 (e) or under 35 U.S.C 120, 121, or 365 (c ) is acknowledged.
Claim Status
Claims 1-4, 8-25 are pending. Claims 1, 4, 8, 10, 13, 19-21, were amended. Claims 24-25 are new; and Claims 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b).
Claims 1-4, 8-20 and 24-25 are under examination.
The examiner notes that claim 10 is currently amended however the claim status is “Previously presented”. Thus, it is respectfully requested that Applicants identify each claim with the appropriate status in subsequent claim listings.
Response to Amendment
The declaration under 37 CFR 1.132 filed April 23, 2025 is insufficient to overcome the rejection of claims 1-20 based upon insufficiency of disclosure under 35 U.S.C. 112(a) as set forth in the Office Action mailed on 12/23/2024, because the proffered data is insufficient evidence that Applicants were in possession of the claimed invention at the time of filing of the instant application. Written description must be supported in the original filing, not reconstructed. To show invention as required by 35 U.S.C. 112(a), the disclosure must convey the Applicants had possession of the claimed subject matter as of the filing date. A claim to a genus, such as in the instant case, must be supported by a representative number of species falling within the scope of the genus or structural features common to the members of the genus such that the artisan of ordinary skill can visualize or recognize the members of the genus to show possession at the time of filing. The post-filing data in the declaration does not clearly establish Applicants were in possession of the information to support variants of SEQ ID NO: 1 and/or an effective amount of the peptide, thus incorporating the evidence as support for the claimed genus of species would be interpreted as new matter.
Response to Arguments
1. Applicants’ arguments, see Remarks, filed 02/03/2026, with respect to the claim objections, have been fully considered and are persuasive. The objections to claims 1 and 13 have been withdrawn.
2. Applicants’ arguments, see Remarks, filed 02/03/2026, with respect to the 35 U.S.C. 112(b) rejection, have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection to claims 3-9, 19 and 20 has been withdrawn.
3. Applicants’ arguments, see Remarks, filed 02/03/2026, with respect to the 35 U.S.C. 112(b) rejection, have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejection to claims 3-9, 13 19 and 20 has been withdrawn.
4. Applicants’ arguments, see Remarks, filed 02/03/2026, with respect to the 35 U.S.C. 112(a) rejection (i.e., new matter), have been fully considered and are persuasive. The 35 U.S.C. 112(a) rejection to claims 1-9, 15, 17 and 19 has been withdrawn.
5. Applicants’ arguments, see Remarks, filed 02/03/2026, with respect to the 35 U.S.C. 112(a) rejection (i.e., new matter), have been fully considered and are persuasive. The 35 U.S.C. 112(a) rejection to claims 10-14, 16, 18 and 20 has been withdrawn.
6. Applicants’ arguments, see Remarks, filed 02/03/2026, with respect to the 35 U.S.C. 112(a) rejection (i.e., writing description), have been fully considered but are not are persuasive. The 35 U.S.C. 112(a) rejection to claims 1-9, 15, 17 and 19 has been maintained.
7. Applicants’ arguments, see Remarks, filed 02/03/2026, with respect to the 35 U.S.C. 112(a) rejection (i.e., written description), have been fully considered but are not are persuasive. The 35 U.S.C. 112(a) rejection to claims 10-14, 16, 18 and 20 has been maintained.
New Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
1. Claims 1-4, 8-20, and 24-25 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.
Amended claims 1 and 10 include an effective amount of SVTEQGAELSNEER (SEQ ID NO: 1), or a variant thereof. The amended claims also recite that “SEQ ID NO: 1 or a variant thereof consists of 10 to 13 amino acids”, and that the variant is modified “with up to 4 amino acid deletions from the N-terminus, the C-terminus or both the N-terminus and the C-terminus.” The claim is internally inconsistent because the transitional phrase “consist of” limits the length of SEQ ID NO: 1 or a variant thereof to a specific length (i.e., 10, 11, 12 and 13 amino acids). Thus a variant of SEQ ID NO: 1 consisting of 10 amino acids in length that is modified by deleting 4 amino acids from the from the N-terminus and 4 amino acids from the from the C-terminus would result in a variant of two amino acids in length (i.e., a dipeptide). Therefore, the instantly claimed method as recited in claims 1-4, 8-20 and 24-25 is inconsistent, because Applicants have failed to particularly point out and distinctly claim the subject matter regarded as the invention.
Claim Rejections - 35 USC § 102
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.
2. Claims 1-2, 10-20 and 24-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9,597,368 B2 Date of Patent: Mar. 21, 2017 (herein after “US ‘368”), as evidenced by Draper, H.H. (1994). Bone Loss in Animals. In: Draper, H.H. (eds) Nutrition and Osteoporosis. Advances in Nutritional Research, vol 9. Springer, Boston, MA. https://doi.org/10.1007/978-1-4757-9092-4_3 (herein after “Draper”).
US ‘368 discloses a method for treatment of a T-cell mediated autoimmune disease, comprising administering to a patient in need thereof: a peptide consisting of no more than 20 amino acids and comprising N′-SVTEQGAELSNEER-C′ (SEQ ID NO: 1) or an analogue or variant thereof that inhibits T cell migration; or a chimeric or fusion protein comprising said peptide, wherein the disease is selected from the group consisting of diabetes mellitus (type 1), rheumatoid arthritis, Crohn's disease and uveitis (see column 27, claim 1). US ‘368 also claims that the peptide, analogue variant, or chimeric or fusion protein thereof as defined in claim 1 is administered in the form of a pharmaceutically acceptable composition (see column 28, claim 6). Thereby, US ‘368’s N′-SVTEQGAELSNEER-C′ sequence represented by SEQ ID NO: 1 corresponds to instant SVTEQGAELSNEER (SEQ ID NO: 1) or a variant thereof.
With respect to administering an effective amount of SEQ ID NO: 1 or a variant thereof:
Pursuant to MPEP 2111, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The instant specification recites that “six-week-old male wild-type mice were treated with or without daily intraperitoneal (i.p.) injections of PEPITEM (300 μg) for 2 weeks”(see pg. 32, para[0146]). Therefore the effective amount of SVTEQGAELSNEER (SEQ ID NO: 1) administer as part of the claimed method is being interpreted as 300 μg.
US ‘368 discloses Example 1, wherein the peptide was injected at a final concentration of 300
μg/mouse (see column 12, lines 11-13). Since US ‘368 discloses administering the same amount of the same peptide to the same subject (i.e., mouse), then it is inherent that administering 300ug of SVTEQGAELSNEER (SEQ ID NO: 1) per mouse will result in the claimed functions of reducing bone loss, stimulating bone production, or both.
With respect to the patient population (i.e., a patient in need thereof):
As evidenced by Draper, and as concluded by previous authors, aging bone loss is universal (Garn et al 1967) (see pg. 53, Introduction). Draper adds that when Garn et al. concluded that aging bone loss is universal, they were referring to the human species. However, subsequent research has shown that this conclusion extends to all other species of vertebrates so far examined, from laboratory rodents to non-human species living in the wild (see pg. 53, Introduction).
As such, the scope of the instantly claimed method of reducing bone loss, stimulating bone production, or both encompasses the human species as well as all other species of vertebrates such as laboratory rodents, because all species of vertebrates lose bone due to aging, thereby all species of vertebrates from laboratory rodents to humans are in need of reducing bone loss, stimulating bone production, or both.
As such, US ’368’s method for treatment of a T-cell mediated autoimmune disease comprising administering to a patient in need thereof: a peptide consisting of no more than 20 amino acids and comprising N′-SVTEQGAELSNEER-C′ (SEQ ID NO: 1) or an analogue or variant thereof that inhibits T cell migration anticipates the instantly claimed method as recited in instant claims 1-2.
Regarding claims 10-14, it is noted that the instant specification does not define what constitutes “musculoskeletal loss”. Pursuant to MPEP 2111.01, under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention.
WHO teaches that musculoskeletal health refers to the performance of the locomotor system comprising intact muscles, bones, joints and adjacent connective tissue (see WHO, Musculoskeletal health, 14 Jul 2022, retrieved from https://www.who.int/news-room/fact-sheets/detail/musculoskeletal-conditions, on 06/11/2026). WHO adds that musculoskeletal conditions include conditions that affect joints (e.g., osteoarthritis, rheumatoid arthritis, psoriatic arthritis, gout, spondyloarthritis); bones (e.g., osteoporosis, osteopenia and associated fragility fractures, traumatic fractures); muscles (e.g., sarcopenia); multiple body areas or systems, such as regional (e.g. back and neck pain) and widespread (e.g. fibromyalgia) pain conditions, inflammatory diseases such as connective tissue diseases and vasculitis that have musculoskeletal manifestations, for example systemic lupus erythematosus, or amputation as a result of disease or trauma (see WHO, pg. 2).
As such, the scope of “musculoskeletal loss” is being interpreted as the loss of performance of the locomotor system, and encompasses conditions that affect the integrity of, joints, bones, muscles and multiple body areas or systems; those conditions including but not limited to: osteoarthritis, rheumatoid arthritis, psoriatic arthritis, gout, spondyloarthritis, osteoporosis, osteopenia and associated fragility fractures, traumatic fractures, sarcopenia, regional and widespread pain conditions (i.e., fibromyalgia), inflammatory diseases such as connective tissue diseases and vasculitis that have musculoskeletal manifestations, for example systemic lupus erythematosus, or amputation as a result of disease or trauma.
As previously discussed, US ’368 discloses a method for treatment of a T-cell mediated autoimmune disease, comprising administering to a patient in need thereof: a peptide consisting of no more than 20 amino acids and comprising N′-SVTEQGAELSNEER-C′ (SEQ ID NO: 1) or an analogue or variant thereof that inhibits T cell migration; or a chimeric or fusion protein comprising said peptide, wherein the disease is selected from the group consisting of diabetes mellitus (type 1), rheumatoid arthritis, Crohn's disease and uveitis (see column 27, claim 1). Then, US ‘368 method of treatment anticipates the instantly claimed method of treatment, prophylaxis, or both of musculoskeletal loss, as recited in instant claims 10-14.
Regarding claims 15-18, US ’368 discloses that the peptide acts upon the individual to which it is administered, and that the individual is a mammal, optionally, a rodent such as a rat or a mouse or a primate, particularly an ape or human (see column, 2, lines 56-57 and 59-61).
Additionally, as previously discussed, US ‘368 discloses administering 300ug of peptide per mouse. An ordinary skilled artisan would have been able to use the teachings of US ‘368 to determine the optimal effective amount of SEQ ID NO: 1 needed to achieve the desired results in a human.
Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. Thus, an ordinary skilled artisan would have been motivated to modify the effective amount as taught by US ‘368, because an ordinary skilled artisan would have been able to scale up the amount of peptide administered with a reasonable expectation of success. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the effective amount administered to human mammal would have been obvious at the time of Applicant's invention.
Regarding claims 19-20, US ’368 discloses that administration of the peptide may be by delivery of the peptide per se, for instance in the form of a pharmaceutically acceptable formulation to the blood by injection, this may be intramuscularly or subcutaneously (see column 4, lines 18-24).
Regarding claims 24-25, US ’368 discloses that the preferred peptide is 14 amino acids long, although the peptide can also be as few as 13, 12, 11 or 10 amino acids or as many as 15, 16, 17 18, 19 or 20 amino acids (see column 2, lines 23-26). Where amino acids are added or removed, these are preferably to or from the N and/or C terminus of the peptide (see column 2, lines 26-27). Other modifications to the chemical structure that protect the peptide from degradation or clearance in vivo are also preferred variants, for example but not restricted to, PEGylation which utilizes a linker or spacer as is known in the art (see column 2, lines 28-31). Thereby, PEGylation at the N or C-terminus would correspond to modification with a chemical moiety as recited in instant claims 24-25.
Accordingly, the disclosure of US ‘368 anticipates instant claims 1-2, 10-20 and 24-25.
Maintained/Modified Rejections in light of Amendment
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.
4. Claims 1-9, 15, 17, 19 and 24 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.
Claims 1-9, 15, 17, 19 and 24 are directed to the administration of a variant of the amino acid sequence SVTEQGAEKSNEER (SEQ ID NO: 1) in an amount effective to reduce bone loss and/or stimulate bone production. An “effective amount” refers to concentrations of the peptide that lead to an enhanced rate of bone formation relative to bone resorption. See paragraph [0077] in the instant specification. The claimed variant consists of 10 to 13 amino acids and the amino acid sequence of the variant is of SEQ ID NO: 1 modified: (i) with up to 4 amino deletions from the N-terminus, the C-terminus or both the N-terminus and the C-terminus; or (ii) with a chemical moiety at the N-terminus, the C-terminus, or both the N-terminus and the C-terminus.
Applicants have not disclosed a variant of SEQ ID NO: 1 consists of 10 to 13 amino acids and has (i) up to 4 amino acid deletions from the N-terminus, the C-terminus or both the N-terminus and the C-terminus, (ii) a chemical moiety at the N-terminus, the C-terminus, or both the N-terminus and the C-terminus. There is no support in the specification of a peptide having all of the modifications claimed.
The claims also encompass embodiments where the variants comprise up to 4 amino acid deletions on both the N-terminus and C-terminus. Therefore, the scope of amended claim 1 encompasses peptides that are 6 amino acids in length; and there is no support in the specification for variants comprising less than 10 amino acids. The specification teaches that the preferred peptide is 14 amino acids in length, the peptide can also be as few as 10 amino acids or as many as 20 amino acids, where amino acids are added or removed, these are preferably to or from the N and/or C terminus of the peptide. See para. [0080] in the specification.
With respect to the administration of a variant of the amino acid sequence SVTEQGAEKSNEER (SEQ ID NO: 1) in an amount effective to reduce bone loss and/or stimulate bone production. An “effective amount” refers to concentrations of the peptide that lead to an enhanced rate of bone formation relative to bone resorption. See paragraph [0077] in the instant specification. The claimed variant consists of 10 to 13 amino acids and the amino acid sequence of the variant is of SEQ ID NO: 1 modified (i) with up to 4 amino acid deletions from the N-terminus, the C-terminus or both the N-terminus and the C-terminus, or (ii) with a chemical moiety at the N-terminus, the C-terminus, or both the N-terminus and the C-terminus. The claims encompass a large group of peptide variants, including peptides that do not share a single amino acid, that stimulate bone production and reduce bone loss.
Applicant reduced to practice a single peptide; the peptide consisting SEQ ID NO: 1, also referred to as PEPTIEM. See e.g., paragraph [0082]. No other peptides or variants were reduced to practice. The prior art discloses numerous peptide sequences that are variants of SEQ ID NO: 1 as claimed. See for example, US 2015/0051137 A1; paragraphs [0010, 0011]. However, the peptides of the prior art are not taught to possess the function of stimulating bone production and reducing bone loss. Although conservative amnio acid substitutions tend to preserve protein structure and function, the effect depends on many factors include substitutions in active sites, binding interfaces, or structurally critical regions can alter activity, stability, or interactions despite being conservative. Without guidance in the prior art or in the instant disclosure regarding how changes in SEQ ID NO: 1 effect the function of reducing bone loss and stimulating bone production, the skilled artisan would be unable to ascertain peptides that are structural variants of SEQ ID NO: 1 that reduce bone loss and stimulate bone production, from those structural variants that do not reduce bone loss and stimulate bone production.
Given the large breath of the claimed variants, the lack of structure/function correlation in the instant specification and in the prior art with respect to the amino acids required for the function of bone loss reduction and bone production and the lack of a representative number of species of variants of SEQ ID NO: 1 as claimed, one of ordinary skill in the art would conclude that Applicants were not in possession of the claimed genus of variant peptides that reduce bone loss and stimulate bone production. The artisan would conclude Applicant was only in possession of administering a peptide consisting of the amino acid sequence SVTEQGAELSNEER (SEQ ID NO:1) to a patient in need of stimulating bone production and reducing bone loss, a bone cell and a bone cell precursor.
5. Claims 10-14, 16, 18, 20 and 25 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 claimed invention is directed to the administration of a variant of the amino acid sequence SVTEQGAEKSNEER (SEQ ID NO: 1) in an amount effective to treat or prophylactically prevent musculoskeletal loss or damage in a patient in need thereof. An “effective amount” refers to concentrations of the peptide that lead to an enhanced rate of bone formation relative to bone resorption. See paragraph [0077] in the instant specification. The claimed variant comprises 10 to 13 amino acids and the amino acid sequence of the variant is a modification of SEQ ID NO: 1, (i) with up to 4 amino acid deletions from the N-terminus, the C-terminus or both the N-terminus and the C-terminus, (ii) with a chemical moiety at the N-terminus, the C-terminus, or both the N-terminus and the C-terminus. The claims encompass a large group of peptide variants, including peptides that do not share a single amino acid, that enhance bone formation relative to bone resorption.
Applicant reduced to practice a single peptide; the peptide consisting SEQ ID NO: 1, also referred to as PEPTIEM. See e.g., paragraph [0082]. No other peptides or variants were reduced to practice. The prior art discloses numerous peptide sequences that are variants of SEQ ID NO: 1 as claimed. See for example, US 2015/0051137 A1; paragraphs [0010, 0011]. However, the peptides of the prior art are not taught to possess the function of stimulating bone production and reducing bone loss. Although conservative amnio acid substitutions tend to preserve protein structure and function, the effect depends on many factors include substitutions in active sites, binding interfaces, or structurally critical regions can alter activity, stability, or interactions despite being conservative. Without guidance in the prior art or in the instant disclosure regarding the how changes in SEQ ID NO: 1 effect the function of reducing bone loss and stimulating bone production, the skilled artisan would be unable to ascertain peptides that are structural variants of SEQ ID NO: 1 that enhance bone formation rate, from those structural variants that do not enhance bone formation rate.
Given the large breath of the claimed variants, the lack of structure/function correlation in the instant specification and in the prior art with respect to the amino acids required for the function of bone production and the lack of a representative number of species of variants of SEQ ID NO: 1 as claimed, one of ordinary skill in the art would conclude Applicants were not in possession of the claimed genus of variant peptides that reduce bone loss and stimulate bone production. The artisan would conclude Applicants were only in possession of administering a peptide consisting of the amino acid sequence SVTEQGAELSNEER (SEQ ID NO:1) to a patient in need to treating or prophylactically preventing musculoskeletal loss or damage.
Response to Arguments
Applicants' arguments filed 02/03/2026 for claims 1-20 as failing to comply with the written description requirement under 35 U.S.C 112(a), have been fully considered but they are not persuasive for the following reasons:
MPEP §2163 states that 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, 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.
Applicants contend that the amendments to claim 1, in view of the description in paragraphs 80-81 of the specification as filed, fully and explicitly disclose the variants (see Remarks, filed 02/03/2026, pg. 7, first two paragraphs).
However, after carefully examining the evidence provided it is evident that the specification does not support the breath of the claims as amended and clearly indicates that applicants were not in possession of the invention at the time of filing. Thus as discussed in the rejection above, Applicants have not disclosed a variant of SEQ ID NO: 1 consists of 10 to 13 amino acids and has (i) up to 4 amino acid deletions from the N-terminus, the C-terminus or both the N-terminus and the C-terminus, (ii) a chemical moiety at the N-terminus, the C-terminus, or both the N-terminus and the C-terminus. There is no support in the specification of a peptide having all of the modifications claimed. The scope of amended claim 1 encompasses peptides that are 6 amino acids in length; and there is no support in the specification for variants comprising less than 10 amino acids. The specification teaches that the preferred peptide is 14 amino acids in length, the peptide can also be as few as 10 amino acids or as many as 20 amino acids, where amino acids are added or removed, these are preferably to or from the N and/or C terminus of the peptide. See para. [0080] in the specification.
Additionally, the importance of structure/function correlations was highlighted by the courts (Abbvie Deutschland v. Janssen Biotech and Centorcor Biologics, App. No. 2013-1338, -1346 (Fed. Cir., July 1, 2014)). The Abbvie case involved antibodies and written description. The court stated: “We have held that “a sufficient description of a genus ... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. at 1350 (quoting Eli Lilly, 119 F.3d at 1568– 69).”. The courts then further stated: “With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus.” (emphasis added) and then state: “Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Ariad, 598 F.3d at 1351 (“[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011) (noting the technical challenges in developing fully human antibodies of a known human protein). It is true that functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002). However, the record here does not indicate such an established correlation. Instead, Abbvie used a trial and error approach to modify individual amino acids in order to improve the IL-12 binding affinity. Moreover, the ’128 and ’485 patents do not describe any common structural features of the claimed antibodies. The asserted claims attempt to claim every fully human IL-12 antibody that would achieve a desired result, i.e., high binding affinity and neutralizing activity, and cover an antibody as different as Stelara, whereas the patents do not describe representative examples to support the full scope of the claims.”
Accordingly, the 35 U.S.C 112(a) rejection to claims 1-20 is maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLAUDIA E ESPINOSA whose telephone number is (703)756-4550. The examiner can normally be reached Monday-Friday 9:30-5:30 EST.
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/CLAUDIA ESPINOSA/Patent Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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