CLAIM INTERPRETATION In the Examination Process 1 Claim

CLAIM INTERPRETATION “In the Examination Process” 1

Claim Interpretation Is the careful consideration of each and every word in a claim to determine what the claim covers. 2

Claim Interpretation MPEP 2111 Claims must be given their broadest reasonable interpretation consistent with the supporting description. In re Hyatt, 211 F. 3 d 1367, 1372, 54 USPQ 2 d 1664, 1667 (Fed. Cir. 2000) 3

Claim Interpretation MPEP 2111 A claim must be interpreted in light of the specification without reading limitations into the claim. 4

Claim Interpretation Definition of Terms 5

Plain Meaning MPEP 2111. 01 Words and phrases in claims must be given their “plain meaning” as understood by one having ordinary skill in the art UNLESS defined by applicant in the specification with “reasonable clarity, deliberateness, and precision”. 6

When is a Claim Term Limited by a Definition in the Specification? § The specification must clearly set forth the definition explicitly and with reasonable clarity, deliberateness, and precision. Teleflex Inc. v. Ficosa North America Corp. , 63 USPQ 2 d 1374, 1381 (Fed. Cir. 2002), Rexnord Corp. v. Laitram Corp. , 60 USPQ 2 d 1851, 1854 (Fed. Cir. 2001), and MPEP 2111. 01. Exemplification is not an explicit definition. § Even “explicit definitions” can be subject 7 to varying interpretations. §

What if there is No Explicit Definition in the Specification? Look to: n The claims themselves and the context of the surrounding words n The prior art n Dictionaries n Encyclopedias n Treatises 8

Tips n Provide Claim breadth commensurate in scope with the disclosure. n Provide claims directed to the inventive concept. n Avoid reach-through claims. 9

Red Flag Terms n Fragments thereof n Analogues thereof n Derivatives thereof n Or derivatives or analogues thereof n Derived from – “A compound of formula II…and its pharmaceutically acceptable salts or derivatives thereof. ” – “A is derived from a group…’’ • May be rejected under 35 USC 112 10

Consisting Essentially of… The transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F. 2 d 549, 551 -52, 190 USPQ 461, 463 (CCPA 1976) 11

Consisting Essentially of… For the purposes of searching for and applying prior art under 35 U. S. C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to “comprising. ” PPG Industries v. Guardian Industries, 156 F. 3 d 1351, 1355, 48 USPQ 2 d 1351, 1355 (Fed. Cir. 1998) 12

Example 1 Term Definition 13

The Claim 1. A martianase compound. 14

The Specification Martianase compounds are useful for the release of water from ancient Martian soil. A martianase compound is a compound having the following structure, or derivatives or metabolites thereof. 15

The Prior Art The prior art discloses a series of compounds that are useful for treating hair loss (alopecia). The compounds of the prior art have the following structure: wherein R 1 is a substituted aryl group. The prior art patent does not disclose a specific embodiment wherein R 1 is a methylphenyl group. There are, however, a number of synthetic schema disclosed and, if one were to select among the various substituents disclosed in the prior art patent, one could arrive at the same compound as that claimed in the application under examination. 16

Analysis Based upon the above facts, the prior art would fail to anticipate the specific martianase compound disclosed in the subject application since there are no specific blaze marks in the prior art patent that would lead one to the instantly claimed compound. (See, e. g. , In re Baird, 16 F. 3 d 380, 29 USPQ 2 d 1550 (Fed. Cir. 1994)). 17

Analysis (cont. ) However, because the definition of a martianase compound disclosed in applicant’s specification includes “derivatives” and “metabolites”, the term martianase would, absent evidence to the contrary, include the compounds of the prior art. 18

Claim Interpretation Effect of the Preamble on Claim Scope 19

PREAMBLE n The determination of whether a preamble limits a claim is made on a case-by-case basis in light of the facts in each case. MPEP 2111. 02. n There is no litmus test in determining when a preamble limits the scope of a claim. Catalina Marketing International Inc. v. Coolsavings. com, Inc. , 62 USPQ 2 d 1781, 1785 (Fed. Cir. 2002). 20

Guidance in determining when a preamble is not likely to limit a claim (1) When the body of the claim following the preamble is a self-contained description of the structure and does not depend on the preamble for completeness, the preamble does not usually limit the claim. Kropa v. Robie, 88 UPSQ 478, 480 -81 (CCPA 1951); Rowe v. Dror, 42 USPQ 2 d 1550, 1553 (Fed. Cir. 1997); and IMS Technology Inc. v. Haas Automation Inc. , 54 USPQ 2 d 1129, 1137 (Fed. Cir. 2000). (2) A preamble that recites the use or purpose of the claimed invention generally does not limit the claim. Catalina Mktg. Int’l v. Coolsavings. com Inc. , 62 USPQ 2 d 1781, 1785 (Fed. Cir. 2002). 21

Guidance in determining when a preamble is not likely to limit a claim (3) If the preamble merely extols benefits or features of the claimed invention and there is no clear reliance on those benefits or features as patentably significant, the preamble is not likely to limit the claim. (e. g. , preamble recites, “[a] head for a lacrosse stick which provides improved handling and playing characteristics. ” STX, LLC v. Brine, Inc. , 54 USPQ 2 d 1347, 1349 (Fed. Cir. 2000). ) 22

Example 2 Preamble 23

The Claim 1. A cancer therapeutic composition comprising a compound of structure A and a pharmaceutically acceptable carrier. 24

The Prior Art Reference A discloses a composition comprising a compound of structure A in a pharmaceutically acceptable carrier. n Reference A teaches that the composition is used as an antiviral therapeutic for treating human immunodeficiency virus type 1 (HIV-1) infections. n 25

Does the prior art support a rejection? 26

Conclusion The compound and composition found in the prior art and in the instant composition are identical. n Therefore, the prior art anticipates the claimed composition. n The preamble of the claim merely recites an intended use of the composition and as such does not limit the claims. Catalina Mktg. Int’l, Inc. v. n Coolsavings. com, Inc. , 289 F. 3 d 801, 808, 62 USPQ 2 d 1781, 1785 (Fed. Cir. 2002) 27

Claim Interpretation Functional Limitations 28

Consideration of Functional Limitations For Purposes of Applying Prior Art (Cont’d) § The strongest rejection to make is one in which the reference explicitly discloses all claimed features or limitations including those recited as functional language. 29

Consideration of Functional Limitations For Purposes of Applying Prior Art (Cont’d) § However, if the prior art fails to explicitly disclose limitations recited as functional language, the examiner should determine: § Whether the prior art discloses all claimed structural limitations and § whether the disclosed structure is capable of performing the recited function. 30

Intended Use Limitation n When a compound or composition is limited by a particular use, enablement of that claim should be evaluated based on that limitation. MPEP 2164. 01(c) n Prior art evaluation may or may not turn based upon an intended use, dependent upon whether the intended use imports structural or other necessary limitations upon the claimed invention. The language used and where it occurs in the claim must be considered. n See Eaton Corp. v. Rockwell International Corp. , 66 USPQ 2 d 1271 (Fed. Cir. 2003). 31

Consideration of Intended Use Limitations for Purposes of Applying Prior Art n If the prior art fails to discuss the intended use and the examiner has a basis for asserting that prior art product is capable of performing in the claimed manner, the claims should be rejected. § “(T)he recitation of a new intended use for an old product does not make a claim to that old product patentable. ” In re Schreiber, 44 USPQ 2 d 1429 (Fed. Cir. 1997). § In the rejection, the examiner should set forth the basis for stating that the prior art is capable of performing the intended use. 32

Example 3 Functional Language 33

Sample Claim 1. A method of enhancing corneal healing comprising: administering to the eye a composition comprising vitamin A and a sterile buffer. 34

Sample Prior Art n Reference A discloses a solution of vitamin A and sterile buffer in the form of eye drops. n Reference A teaches the use of the eyedrops to rewet contact lenses. 35

Does the Prior Art Support a Rejection? n Compare the compositions used n Compare the active steps of the method 36

Conclusion The prior art composition and the instantly claimed invention are identical, as are the methods of administration. n There is no difference between the patient populations in the instant method and the prior art method. n Therefore, the application of the prior arttaught eye drops would inherently result in the enhancement of any corneal healing. n 37

Example 4 Intended Use 38

The Claim n 1. A vaccine comprising an isolated protein comprising SEQ ID NO: 1 or a portion thereof which is antigenic. 39

Examination Procedures n Prior Art • Weight given to the term “vaccine” in the preamble • Claim typically examined as a “composition” (See MPEP 2111. 02) 40

Vaccine n Merck Manual of Diagnosis and Therapy (16 th ed. 1992), p. 21 – A suspension of whole or fractionated microorganisms that have been rendered non-pathogenic, given to induce an immune response and prevent subsequent disease. 41

Vaccine n Dorland’s Medical Dictionary (25 th ed. 1974) – a suspension of attenuated or killed microorganisms administered for the prevention, amelioration, or treatment of infectious diseases 42

Patentability Determination. Vaccine n Prior Art – A reference which discloses the composition comprising the recited protein in a pharmaceutically acceptable carrier would anticipate the claimed invention. – Composition comprising a deleterious substance (sodium azide) would not usually be considered a vaccine 43

Patentability Determination. Vaccine (cont. ) n A reference which contains a composition comprising an antigenic portion of the recited protein would anticipate the claimed invention if the portion elicits a protective immune response. 44

Claim Interpretation Product-by-Process Claims 45

Product by Process Cont. A product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See MPEP 2113. See, e. g. , In re Garnero 162 USPQ 221, 223 (CCPA 1979). 46

Examining Product-by-Process Language (cont’d) Once the examiner provides a rationale which supports the conclusion that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 218 USPQ 289, 292 (Fed. Cir. 1983). A statement or argument by the attorney is not factual evidence. MPEP 716. 01 47

Example 5 Inherent Limitations 48

The Claims 1. An isolated and purified polynucleotide that encodes a protein that binds a black hole growth factor. 2. The polynucleotide of claim 1 comprising SEQ ID NO: 1. 49

The Specification n The specification discloses the isolation of a black hole protein (BHP) from big bang cell line Explodin 1 using a subtraction hybridization methodology. This protein was used to generate antibodies against BHP and these antibodies were used in expression cloning experiments to isolate a c. DNA molecule (SEQ ID NO: 1) from the Explodin 1 cell line that encodes BHP. 50

The Specification (cont. ) n The specification also discloses results from a Southern blot using Explodin 1 DNA that reveals that this cell line has a single Explodin 1 allele. The Southern blot also shows a single 1700 base pair Eco. R 1 genomic DNA fragment that hybridizes with SEQ ID NO: 1. Results of Northern blot experiments reveal a single band when SEQ ID NO: 1 is used as a probe. 51

The Specification (cont. ) n BHP is a 207 kd protein and has seven transmembrane domains. Gene mapping experiments indicate that the BHP gene is present on chromosome 7 at position p 4 (7 p 4). 52

Prior Art (Hawkings et al. ) Hawkings et al. disclose the isolation of a nucleic acid from the Explodin 1 cell line. This nucleic acid encodes a 207 kd protein having seven transmembrane domains. n This protein includes a catalytic domain that is homologous to other cation channels and, when activated using heat, results in the massive expansion of cell size due to an increase in water uptake by a cell. Southern blot experiments reveal that this protein is encoded by a DNA sequence present on a 1700 base pair Eco. R 1 genomic DNA fragment and gene mapping experiments indicate that this fragment of genomic DNA is present on chromosome 7 at position p 4 (7 p 4). n Hawkings et al. disclose the isolation of a c. DNA molecule that encodes the 207 kd protein described, but do not present any sequence information. n 53

Rejection n Claims 1 and 2 are rejected under 35 USC 102 as being anticipated by Hawkings et al. – The instantly claimed invention is drawn to a polynucleotide that encodes a protein that binds to the black hole growth factor (BHGF). Claim 2 recites that this polynucleotide has the sequence set forth in SEQ ID NO: 1. – Hawkings et al. disclose the isolation of a c. DNA molecule that appears to be identical to that instantly claimed. In particular, they disclose the isolation of a c. DNA molecule that maps to chromosome 7 p 4 and encodes a 207 kd protein. – It is noted that Hawkings et al. do not disclose the sequence of the c. DNA or protein or its ability to encode a protein that binds BHGF. However, because their c. DNA was obtained from the same cell line, has the same genomic DNA Southern blot pattern, and maps to the same genomic locus, it appears to be the same polynucleotide as that instantly claimed. 54

Prosecution Issues 1. 2. Applicant may provide a showing that the c. DNA of Hawkings et al. does not encode a protein that binds BHGF. Applicant may provide a showing that indicates that the c. DNA of Hawkings et al. has a sequence other than SEQ ID NO: 1. This showing might overcome a rejection of claim 2, but would not necessarily overcome a rejection of claim 1 in the absence of the showing in (1) above. 55