Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
2. The election filed on 10/01/2025 in response to the Office Action of 08/27/2025 is acknowledged and has been entered.
Applicant has elected an HSP27 polypeptide or an immunologically equivalent portion thereof, as species of pharmaceutical formulation; SEQ ID NO: 1 as species of SEQ ID NOs.
Because applicant did not distinctly and specifically point out any supposed errors in the restriction requirement, the election has been treated as an election without traverse. See MPEP 818.03(a).
3. Claims 29-48 are pending in the application. Claims 35-36 and 39-41 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/01/2025.
Claims 29, 30-34, 37-38 and 42-48 are currently under prosecution.
Priority
Applicant’s claim under 35 U.S.C. §§ 119(e) and/or 365(c) for benefit of the earlier filing date of applications, is acknowledged.
Improper Markush Grouping Rejection
6. Claims 30 and 32-34 are 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 § 706.03(y).
The Markush grouping of the nucleic acids of claim 30 or the polypeptides of claims 32-34 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: because the nucleic acids of claim 30 or the polypeptides of claims 32-34 do not share a “single structural similarity”.
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.
7. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
8. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
9. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
10. Claims 29, 38, 42, 43, 44, 45 and 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshio et al. (JP 2018132471, published on 08/23/2018) evidenced by Machine Translation of JP 2018132471 (published on 08/23/2018, pages 1-37), in view of De et al. (US 20010049357, IDS).
Claims 29, 38, 42, 43, 44, 45 and 46-48 are herein drawn to a method for treating non-alcoholic fatty liver disease, the method comprising administering to a human subject in need thereof a pharmaceutical formulation comprising an HSP27 polypeptide or an immunologically equivalent portion thereof, wherein the pharmaceutical formulation is administered in an effective amount to treat non-alcoholic fatty liver disease in the subject.
Yoshio et al. teach a treatment method for non-alcoholic fatty liver disease, wherein the non-alcoholic fatty liver disease is accompanied by an inflammation and with higher level of HSP27; see entire document, abstract/overview, claim 4, [0012] and [0077] of Machine Translation of JP 2018132471. Yoshio et al. teach the nonalcoholic fatty liver disease is a non-alcoholic steatohepatitis (instant claim 48); see abstract/overview.
Yoshio et al. do not teach inhibiting inflammation using an HSP27 polypeptide.
However, this deficiency is remedied by De et al.
De et al. teach a method of inhibiting an inflammatory response in a mammal, the method comprising administering to the mammal a therapeutically effective amount of Hsp 27; see entire document, e.g., title, abstract, claim 1. De et al. teach a composition comprising an effective amount of Hsp 27 and a pharmaceutically acceptable carrier (instant claim 46); see [0007].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to treat non-alcoholic fatty liver using an HSP27 polypeptide. One would have been motivated to do so because Yoshio et al. teach that non-alcoholic fatty liver is accompanied by an inflammation and with higher level of HSP27; De et al. teach a method of inhibiting an inflammatory response in a mammal, the method comprising administering to the mammal a therapeutically effective amount of HSP27. Thus, one of ordinary skill in the art would have a reasonable expectation of success that by combining the teachings of the references so as to treat non-alcoholic fatty liver using an HSP27 polypeptide, because the non-alcoholic fatty liver is accompanied by an inflammation and with higher level of HSP27, and the inflammation of non-alcoholic fatty liver can be inhibited by HSP27 polypeptide as taught by the references.
For claims 38 and 42-43, a wherein clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited, MPEP 2111.04.
For claims 44-45 and 47, with regard to dose, schedules, and routes of administration recited in claims 44-45 and 47, it would have been prima facie obvious to one ordinarily skilled in the art at the time the invention was made to have determined the most appropriate doses, schedules, and routes of administration, so as to practice the disclosed process of treating the condition as effectively as possible, because dose, route of administration, application scheme, repetition and duration of treatment will be in general dependent on the nature of the disease (type, grade, and stage of the tumor etc.) and the patient (constitution, age, gender etc.), and will be determined by the medical expert responsible for the treatment. Thus, one ordinarily skilled in the art before the effective filing date of the claimed invention would have a reasonable expectation of success to do so to optimize the effectiveness of the treatment. Applicant is reminded that it is a common objective in the art to establish a dose, schedule, and route of delivery that is both safe and effective, so as to achieve optimal therapeutic effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). See In re Peterson, 65 USPQ2d 1379 1382 (CA FC 2003): “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”
11. Claims 29, 31, 34 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshio et al. (JP 2018132471, published on 08/23/2018) evidenced by Machine Translation of JP 2018132471 (published on 08/23/2018, pages 1-37), in view of De et al. (US 20010049357, IDS) as applied to claims 29, 38, 42, 43, 44, 45 and 46-48 above, and further in view of Prinz et al. (US 20110033479, published on 02/10/2011).
Claims 31, 34 and 37 are herein drawn to the method of claim 29, wherein the HSP27 polypeptide comprises SEQ ID NO: 2, or SEQ ID NO: 25, and a composition comprises an adjuvant.
The teachings of Yoshio et al. in view of De et al. have been set forth in the above rejection of claims 29, 38, 42, 43, 44, 45 and 46-48 under 35 U.S.C. 103.
Yoshio et al. in view of De et al. do not teach the HSP27 polypeptide comprises SEQ ID NO: 2 or SEQ ID NO: 25, and an adjuvant.
However, these deficiencies are remedied by Prinz et al.
Prinz et al. teach HSP27 comprising SEQ ID NO: 4; see entire document, e.g., [0070-0071]. SEQ ID NO: 4 of Prinz et al. is 100 % identical with instant claimed SEQ ID NOs: 2 and 25; see sequence alignment below. Prinz et al. teach a pharmaceutical composition comprising an adjuvant; see [0130], [0132] and [0142].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the references so as to treat non-alcoholic fatty liver using an HSP27 polypeptide comprising SEQ ID NO: 2 or SEQ ID NO: 25. One would have been motivated to do so because Yoshio et al. in view of De et al. teach a method of treating non-alcoholic fatty liver using an HSP27 polypeptide; Prinz et al. teach HSP27 comprising SEQ ID NO: 4 which is 100 % identical with instant claimed SEQ ID NOs: 2 and 25. Thus, one of ordinary skill in the art would have a reasonable expectation of success that by combining the teachings of the references so as to substitute the HSP27 polypeptide of Yoshio et al. in view of De et al. for another HSP27 polypeptide of Prinz et al. to arrive the instant claimed invention, because simple substitution of the HSP27 polypeptide of Yoshio et al. in view of De et al. for another HSP27 polypeptide of Prinz et al. would obtain predictable results.
Given the examination guidelines for determining obviousness under 35 U.S.C. 103 in view of the Supreme Court decision in KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007) and the Examination Guidelines set forth in the Federal Register (Vol. 72, No. 195, October 10, 2007) and incorporated recently into the MPEP (Revision 9, March 2014), the following rationales to support rejection under 35 U.S.C. 103(a) are noted:
A) Combining prior art elements according known methods to yield predictable results.
B) Simple substitution of one known element for another to obtain predictable results.
C) Use of known technique to improve similar devices (methods, or products) in the same way.
D) Applying known technique to a known device (method, or product) ready for improvement to yield predictable results.
E) “Obvious to try” --- choosing form a finite number of identified, predictable solutions, with a reasonable expectation of success.
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art.
G) Some teachings, suggestion, or motivation in the prior art that would lead to one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In this case, simple substitution of HSP27 polypeptide of Yoshio et al. in view of De et al. for another HSP27 polypeptide of Prinz et al. would obtain predictable results.
Obviousness is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR International Co. V. Teleflex Inc. 82 USPQ2d 1385 (2007). From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Conclusion
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YAN XIAO/Primary Examiner, Art Unit 1642
Sequence alignment
US-12-918-459-4
Filing date in PALM: 2010-10-26
Sequence 4, US/12918459
Publication No. US20110033479A1
GENERAL INFORMATION
APPLICANT: Ludwigs-Maximilians-Universitaet Muenchen
TITLE OF INVENTION: Proteins Ezrin, Serpin B5, Peroxiredoxin-2 and Heat shock protein
TITLE OF INVENTION: beta-1 as autoantigens for psoriasis vulgaris and
TITLE OF INVENTION: poststreptococcal diseases
FILE REFERENCE: 10072-002US1
CURRENT APPLICATION NUMBER: US/12/918,459
CURRENT FILING DATE: 2010-08-19
PRIOR APPLICATION NUMBER: PCT/EP2008/008267
PRIOR FILING DATE: 2008-09-29
NUMBER OF SEQ ID NOS: 325
SEQ ID NO 4
LENGTH: 205
TYPE: PRT
ORGANISM: Homo sapiens
FEATURE:
NAME/KEY: misc_feature
OTHER INFORMATION: SEQ ID NO: 4 shows the sequence of Heat shock protein beta-1
(Name of protein: Heat shock protein beta-1; Synonyms: HspB1,
etc; Name of gene: HSPB1; Synonyms HSP27; from Homo sapiens
(TaxID: 9606); GI-Nummer: GI32477; UniProtKB/Swiss-Prot entry
Query Match 100.0%; Score 1091; Length 205;
Best Local Similarity 100.0%;
Matches 205; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MTERRVPFSLLRGPSWDPFRDWYPHSRLFDQAFGLPRLPEEWSQWLGGSSWPGYVRPLPP 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MTERRVPFSLLRGPSWDPFRDWYPHSRLFDQAFGLPRLPEEWSQWLGGSSWPGYVRPLPP 60
Qy 61 AAIESPAVAAPAYSRALSRQLSSGVSEIRHTADRWRVSLDVNHFAPDELTVKTKDGVVEI 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 AAIESPAVAAPAYSRALSRQLSSGVSEIRHTADRWRVSLDVNHFAPDELTVKTKDGVVEI 120
Qy 121 TGKHEERQDEHGYISRCFTRKYTLPPGVDPTQVSSSLSPEGTLTVEAPMPKLATQSNEIT 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TGKHEERQDEHGYISRCFTRKYTLPPGVDPTQVSSSLSPEGTLTVEAPMPKLATQSNEIT 180
Qy 181 IPVTFESRAQLGGPEAAKSDETAAK 205
|||||||||||||||||||||||||
Db 181 IPVTFESRAQLGGPEAAKSDETAAK 205
US-12-918-459-4
Filing date in PALM: 2010-10-26
Sequence 4, US/12918459
Publication No. US20110033479A1
GENERAL INFORMATION
APPLICANT: Ludwigs-Maximilians-Universitaet Muenchen
TITLE OF INVENTION: Proteins Ezrin, Serpin B5, Peroxiredoxin-2 and Heat shock protein
TITLE OF INVENTION: beta-1 as autoantigens for psoriasis vulgaris and
TITLE OF INVENTION: poststreptococcal diseases
FILE REFERENCE: 10072-002US1
CURRENT APPLICATION NUMBER: US/12/918,459
CURRENT FILING DATE: 2010-08-19
PRIOR APPLICATION NUMBER: PCT/EP2008/008267
PRIOR FILING DATE: 2008-09-29
NUMBER OF SEQ ID NOS: 325
SEQ ID NO 4
LENGTH: 205
TYPE: PRT
ORGANISM: Homo sapiens
FEATURE:
NAME/KEY: misc_feature
OTHER INFORMATION: SEQ ID NO: 4 shows the sequence of Heat shock protein beta-1
(Name of protein: Heat shock protein beta-1; Synonyms: HspB1,
etc; Name of gene: HSPB1; Synonyms HSP27; from Homo sapiens
(TaxID: 9606); GI-Nummer: GI32477; UniProtKB/Swiss-Prot entry
Query Match 100.0%; Score 207; Length 205;
Best Local Similarity 100.0%;
Matches 36; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MTERRVPFSLLRGPSWDPFRDWYPHSRLFDQAFGLP 36
||||||||||||||||||||||||||||||||||||
Db 1 MTERRVPFSLLRGPSWDPFRDWYPHSRLFDQAFGLP 36