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 .
Claims 1-18 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
It is noted that the foreign priority document is not in English, and no certified translation has been provided. Therefore, the effective filing date for prior art purposes is the international filing date of 10-19-2022.
Election/Restrictions
Applicant's election with traverse of species Weissella cibaria SGW054 in the reply filed on 4-27-2026 is acknowledged. The traversal is on the ground(s) that Baek does not disclose any therapeutic effect of Weissella cibaria JW15 for Parkinson’s disease, Alzheimer’s disease or any other neurodegenerative disease. This is not found persuasive because the claims are drawn to a product and the product, and its properties are inseparable. As such, those properties are necessarily present. Furthermore, the “for prevention or treating” is an intended use that does not distinguish the pharmaceutical composition that is provided for another use.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-15 and 17 are under examination. Claims 16 and 18 are withdrawn from consideration.
Information Disclosure Statement
The information disclosure statement has been considered. An initialed copy is enclosed.
Claim Rejections - 35 USC § 112
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 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(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.
Claims 1-15 and 17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In re Wands, 8 USPQ2d 1400 (1988), provided factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112 (a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. They are:
(1) The nature of the invention
(2) The state of the prior art
(3) The predictability or lack thereof in the art
(4) The amount of direction or guidance present
(5) The presence or absence of working examples
(6) The breadth of the claims
(7) The quantity of experimentation needed, and
(8) The level of skill in the art
It is noted that all of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The claims are drawn in part to a product comprising and Weissella cibaria strain which is a pharmaceutical, food or animal feed product with the intended use for preventing or treating a neurodegenerative disease. The specification solely provides for in vitro results of killing Proteus mirabilis, reduction of lipopolysaccharide (LPS) induced neurotoxicity induce apoptosis of neurons and inhibitory effect on aggregation of alpha-synuclein. The specification provides for no in vivo results of administration of a pharmaceutical composition comprising any of the strains by conventional routes such as parenteral, intramuscular, subcutaneous, or oral. The specification does not teach a food or animal feed comprising the Weissella cibaria strain that has efficacy in preventing or treating any of the neurodegenerative diseases listed in claim 8. These in vitro models are not generally accepted as reasonably predictive of efficacy in vivo.
The State of the Prior Art and the Predictability or lack thereof in the art
Applicant provided no examples for the treatment or prevention of a neurodegenerative disease, including the specific neurodegenerative diseases as claimed in claim 8. The generally accepted definition of the phrase “preventing a disease” is to keep the disease from occurring, or to anticipate it and treatment is the relief of symptoms of the disease. Therefore, by Examiner’s broadest reasonable interpretation of the claims to the Applicant’s method for preventing a neurodegenerative disease, the “preventing” or “treating” of said disease lacks enablement due to the undue amount of experimentation required by one of ordinary skill in the art to predictably practice the claimed method of preventing a neurodegenerative diseases as broadly and specifically claimed. Treatment of neurodegenerative diseases of the central nervous system is complicated by the physiology of the blood-brain barrier and the need for agents to cross this barrier in order to access the central nervous system neurons. The skilled artisan would be unable to determine how to administer the claimed bacteria to the central nervous system to provide for treatment or prevention of neuronal deterioration. The effect of any of the administration of bacteria to the central nervous system for the prevention or treatment of disease is unknown. Bacteria per se are well established to cause meningitis, encephalitis and brain abscesses. The prior art fails to provide definitive guidance in the causes and subsequent prevention and treatment of neurodegenerative diseases, and the guidance that the prior art does set forth are not related to the claimed probiotic or probiotic-derived compound treatments (Fratiglioni et al, Prevention of common neurodegenerative disorders in the elderly, Exper. Gerontol., 44, 46-50, 2009 but published online June 24, 2008). Each of the recited neurodegenerative diseases have different disease processes and different symptoms. No universal drug is known to provide for treatment or prevention of the broad category of diseases that result in neurodegeneration, or all of the diseases as claimed.
Additionally, the use of probiotics or probiotic-derived compounds in the prior art is generally attributed to oral or topical routes of administration. Oral administration is by far the most common method of probiotic administration, and the present disclosure supports this in Example 5. Topical administration of probiotics or probiotic-derived compounds has been disclosed for topical or skin diseases or disorders, for example to treat eczema or skin pathogen infections (Lopes et al. Topical application of probiotics in skin: adhesion, antimicrobial and antibiofilm in vitro assays. J Appl Microbiol. 2017 Feb;122(2):450-461.Published online Dec 12, 2016.). Administration of probiotics or probiotic-derived compounds by injection or inhalation is not well-established in the prior art. Applicant discloses no examples of injection or inhalation administrations of the present invention. Therefore, by Examiner’s broadest reasonable interpretation of pharmaceutical compositions, the injection or inhalation administration routes lack enablement due to the undue amount of experimentation required by one of ordinary skill in the art to predictably and safely administer the present invention to a subject in need by the claimed injection or inhalation routes.
The Amount of Direction or Guidance Present and Presence or Absence of Working Examples
There are no embodiments or examples in the present disclosure that demonstrate or elaborate on the treatment or prevention of neurodegenerative diseases. Examiner notes that examples provide in vitro inflammatory models using LPS, infection and neuronal abnormalities but only provides in vitro evidence, which the art does not recognize a reasonable correlation with efficacy in vivo. Additionally, prevention of Parkinson’s disease, and in fact any disease, is understood by one of ordinary skill in the art to include the prevention of the onset of any and all symptoms of the disease. The present disclosure is silent on the prevention of all the other symptoms of Parkinson’s disease or any other neurodegenerative disease.
Claim 15 claims a method to prevent or treat a group of neurodegenerative diseases. The present disclosure provides no working examples or guidance on how the present invention can be used to prevent or treat such disorders. The prior art is also silent on how a probiotic can be used to prevent or even treat any of the recited neurodegenerative diseases or neurodegenerative disease in particular. In the absence of proper guidance by the present disclosure, the method of preventing or treating neurodegeneration lacks enablement due to the undue amount of experimentation required by one of ordinary skill in the art to predictably use the present invention to prevent or treat a learning disorder, cognitive impairment, or memory impairment.
Additionally, the present disclosure fails to demonstrate the treatment or prevention of the symptoms in other neurodegenerative diseases. Ataxia symptoms from other neurodegenerative diseases could be due to other modes of action, and applying the results of a Parkinson’s disease related ataxia mouse model experiment of symptom prevention would not necessarily be transferable to preventing or treating, for example, Friedreich Ataxia ("Friedreich's Ataxia Fact Sheet", NINDS, Publication date June 2018, https://www.ninds.nih.gov/friedreich-ataxia-fact-sheet, NIH Publication No. 18-NS-87) which is a hereditary neurodegenerative disease that results in symptoms of ataxia because peripheral nerve cells build up toxic byproducts from energy production. The specification does not provide evidence of treating or preventing neurodegeneration in vivo in any animal model of neurodegenerative disease. No art accepted correlation between the in vitro tests and the in vivo diseases has been presented for any neurodegenerative disease, including Parkinson’s. Therefore, by Examiner’s broadest reasonable interpretation of the claims, the method for preventing disease or treating symptoms disease in a subject having neurodegenerative disease lacks enablement due to the undue amount of experimentation required by one of ordinary skill in the art to predictably use the present invention to prevent or treat symptoms of ataxia in other non-Parkinson’s disease neurodegenerative diseases.
The Breadth of the Claims
The present invention’s breadth of the rejected claims is broader than the disclosure; specifically, the instant claims include preventing a generic neurodegenerative disease, whereas the disclosure only supports in vitro assays that lack correlation with any in vivo animal model of the claimed disease.
The Quantity of Experimentation Needed and the Level of Skill in the Art
While the level of skill in the pharmaceutical arts is high, it would require undue experimentation for one of ordinary skill in the pertinent art to (1) prevent any neurodegenerative disease, (2) prevent or treat a neurodegenerative disease , (3) prevent or treat symptoms in a generic neurodegenerative disease, or (4) for administering the composition by any means of parenteral, intravenous, subcutaneous, intranasal, inhaled etc.. The science of probiotic development has not evolved such that the above issues could be solved by experimentation methods known by one of ordinary skill in the art.
It is noted that enablement must be established in the specification at the time of filing and is to be commensurate in scope with the stated claimed. In re Hogan and Banks, 194 USPQ 527 (1977). The courts have held that the disclosure is insufficient when testing is necessary to determine the actual use or possible lack of use (In re Kirk and Petrow 153 USPQ 48 (CCPA 1967). The skilled artisan would have to determine, at what particular time, what route of administration, under what conditions and what dose(s) and dosing regimens would be required to treat or prevent neurodegenerative diseases as claimed. These particulars are in fact the act of invention and would require undue and unpredictable experimentation in a field that is known to have few effective drugs and where a single drug is not effective across a broad category of neurodegenerative diseases. Without further guidance or working examples in the present invention’s specification, the claims lack enablement for the claimed invention.
The specification lacks complete deposit information for the deposit of all of the Weissella cibaria strains set forth in claims 2, 3, 11, 12, 14, 15 and 17. Because it is not clear that cell lines possessing the properties of the claimed Weissella cibaria strains are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of the recited Weissella cibaria strains, a suitable deposit of each of the strains for patent purposes is required. Accordingly, filing of evidence of the reproducible production of the bacteria strains as set forth in claims 2, 3, 11, 12, 14, 15 and 17, is required. Without a publicly available deposit of the above cell line, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the cell line is an unpredictable event.
Applicant's referral to the deposit some of the bacterial strains in the specification is an insufficient assurance that all required deposits have been made and all the conditions of 37 CFR §1.801-1.809 have been met.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that (1) the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, (2) that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and (3) that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1) The name and address of the depository;
2) The name and address of the depositor;
3) The date of deposit;
4) The identity of the deposit and the accession number given by the depository;
5) The date of the viability test;
6) The procedures used to obtain a sample if the test is not done by the depository; and
7) A statement that the deposit is capable of reproduction.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If the deposit was made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the hybridoma cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Claim 17 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As to claim 17, the accession number is unclear if it is the deposit related to the claimed strain or if the strain is limited to the deposited strain. If it is Applicant’s intention to limit to the deposited strain the claim should state “A Weissella cibaria SGW054 strain deposited as accession number KCCM13225P.”
Claims 8 and 9 are rejected under 35 U.S.C. 112(d), 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. As to claims 8 and 9, the claim merely recites the intended use of the strain and as such does not provides for any additional structure or elements in the composition and therefore do not properly further limit the composition of claim 1 from which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Instant claim 1, as amended, and claim 2 are directed to a pharmaceutical composition comprising a Weissella cibaria strain of bacterium and dependent claims recite specific strains. Claims 10 and 11 are drawn to food compositions and claim 13-15 are drawn to animal feed compositions. Claim 17 is drawn to a Weissella cibaria SGW054 strain per se. Because the claimed strain(s) and the food/feed are composed of matter, at least one embodiment encompassed within the broadest reasonable interpretation (BRI) of instant claims is directed to a statutory category, i.e., a composition of matter (Step 1: YES). The as-filed specification at does not teach any genetic manipulation of any of the bacterial strains of the claims and therefore the invention encompasses strains isolated from a naturally occurring source, i.e., from nature. The specification teaches that the strains can be isolated from kimchi or tangerines (see page 6, last paragraph). The strains encompass Weissella cibaria strains distributed from the World Institute of Kimchi (KCKM) and the Korea Federation of Culture Collection (KCCM) in Example 2 are encompassed by the generic claims. Therefore, it has been determined that the claimed strain(s) are naturally occurring strains that have been further characterized. There is no evidence that the claimed bacterial strain(s) are modified in any way and the strain(s) are markedly different from what exist in nature. Supreme Court has made it clear in Myriad that eligibility requires the creation of something not naturally occurring, which is markedly different from what exists in nature. Unlike the Chakrabarty bacterium, which was new “with markedly different characteristics from any found in nature” Diamond v. Chakrabarty, 447 U.S. 303 (1980) at 310, 100 S. Ct. 2204, 65 L. Ed. 2d 144, due to the multiple additional plasmids and resultant “capacity for degrading oil”, there is no indication that the instantly claimed strain(s) are genetically manipulated or structurally modified in any marked or significant way such that the structural difference results in change of properties of the strain(s). Furthermore, the recitation of “for preventing or ameliorating a neurodegenerative disease” as recited represent the inherent qualities, properties or characteristics inseparable from said naturally occurring strain(s) and therefore are a handiwork of nature. In Chakrabarty and Myriad, the marked difference inquiry was focused on the modified structural characteristics of the product, not how it was used or how it was made. Note that “….. patents cannot issue for the discovery of phenomena of nature”. Le Roy v. Tatham, 14 How. 156, 175 (1853). The qualities of the bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none.” See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. at 130, 1948. In Funk Brothers, the Court held that the composition was not patent eligible because the patent holder did not alter the bacteria in any way. In the instant case, having two natural strains of Lactococcus lactis bacterium strains in a liquid composition or in natural milk does not add significantly more to the natural products such that it is practically applied. Thus, each component of the instantly claimed product is a ‘product of nature’ exception, and the claims are directed to a judicial exception (Step 2A Prong One: YES). Judicial exceptions include all natural products including those derived from natural sources or patients such as naturally occurring microorganisms, proteins, peptides, glycoproteins, glycopeptides, carbohydrates, and other substances found in or derived therefrom, or from nature. Next, the claims as a whole are analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claims amount to significantly more than the exceptions. Having the two naturally occurring strains in a composition does not amount to significantly more. There is nothing that provides significantly more or that integrates the claimed naturally occurring strains or said strains in food or feed, i.e., the judicial exceptions, into a practical application (Step 2A Prong Two: NO). No structural elements or claim limitations apply or use the exception(s) in any meaningful way and integrate the law of nature into a practical application. The limitation ‘pharmaceutical composition’ “feed or food composition" merely indicates a field of use in which to apply the judicial exceptions and therefore fail to provide meaningful limits on the claims. This is particularly relevant as the strains can be obtained from kimchi. The claims as a whole do not amount to significantly more than ‘products of nature’ (Step 2B: NO). Therefore, the claims are not directed to a patent eligible subject matter. The rationale for this determination is formed in view of the 2019 PEG, the 2015 Update of the 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 4618) (hereafter Interim Eligibility Guidance) dated 16 December 2014, the Life Sciences Examples issued in May 2016, and in view of Myriad v Ambry, CAFC 2014-1361, -1366, 17 December 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June13, 2013).
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.
Claims 1, 4, 6, 7, 8, 9, 10 and 13 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated Oh (US 7,250,162; 2007).
Oh teaches Weisselia cibaria strains Weissella cibaria CMU (KCTC 10650BP), Weissella cibaria CMS-1 (KCTC 10678BP), Weissella cibaria CMS-2 (KCTC 10679BP) or Weissella cibaria CMS-3 (KCTC 10680BP) in a drinkable or eatable lactic acid bacterial formulation prepared from the strains (see column 12, claims 1 and 2). Oh teaches that the strains do not produce harmful metabolites or enzymes and are safe for consumption. They do not show hemolysis, gelatin not liquified, do not produce ammonia, do not produce indole do not produce phenylpyruvic acid, not beta glucuronidase is produced (see column 10 – column 11). Oh teaches the strains in distilled water for oral treatment, held in the oral cavity for one minute and then swallowed (see Example 3, column 7, lines 55-65). Oh teaches the strains in Yogurt goods, Kimchi Goods, butter goods and Gum goods (see column 9, example 1-4). The functional properties of claims 4-7 are inherent to the strain absent factual evidence to the contrary. Since the food product of Oh can also be considered a pharmaceutical, and there is no structural difference between animal feed product and the food product of the claims, the food/feed compositions of Oh anticipate the instant claims.
"Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Since the Office does not have the facilities for examining and comparing applicant's bacterium with the bacterium of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (e.g., that the bacterium of the prior art does not possess the same functional characteristics of the claimed bacterium). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 619 F.2d 67, 205 USPQ 594 (CCPA 1980).
The statement reciting the intended use as a “for preventing or treating a neurodegenerative disease " is not considered a limitation since it does not result in a structural difference; if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”).
Claims 1, 4, 6, 7, 8 and 9, are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated Lee et al (Scientific Reports, 5:17128, pages 1-14; 2015).
Lee et al teach Weissella cibaria KACC 11845 were obtained from the Korean Culture Collection (KACC). Lee teach W. cibaria in sterile M9 buffer (see paragraph bridging pages 9-10). The functional properties of claims 4-7 are inherent to the strain absent factual evidence to the contrary. Since there is no structural difference between the pharmaceutical composition and the composition of Lee et al, the claims are anticipated.
"Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Since the Office does not have the facilities for examining and comparing applicant's bacterium with the bacterium of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (e.g., that the bacterium of the prior art does not possess the same functional characteristics of the claimed bacterium). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 619 F.2d 67, 205 USPQ 594 (CCPA 1980).
The statement reciting the intended use as a “for preventing or treating a neurodegenerative disease " is not considered a limitation since it does not result in a structural difference; if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”).
Conclusion
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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