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
Status of the Claims
Claims 1-9 are pending in this application.
Claims 1-9 are presently under consideration.
Claim Rejections - 35 USC § 112
Claims 8-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for: 1) the improvement of wrinkles with SEQ ID NO: 1; 2) the improvement of skin elasticity with SEQ ID NO: 1; and 3) wound recovery with SEQ ID NO: 1, does not reasonably provide enablement for: 1) the improvement of wrinkles with an amino acid sequence of SEQ ID NO: 1; 2) the improvement of skin elasticity with an amino acid sequence of SEQ ID NO: 1; 3) wound recovery with an amino acid sequence of SEQ ID NO: 1; 4) strengthening of skin barrier with SEQ ID NO: 1; and 5) inhibition of skin aging with SEQ ID NO: 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The MPEP states:
“There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.”
(A) The breadth of the claims; and (B) The nature of the invention;
The claims are drawn to a method of improving a skin condition of a subject comprising administering a peptide consisting of an amino acids sequence of SEQ ID NO: 1. Note that the claim language “consisting of an amino acid sequence of SEQ ID NO: 1” encompasses peptides that comprise the full-length sequence of SEQ ID NO: 1 or any portion of SEQ ID NO: 1.
(C) The state of the prior art;
No prior art was found that suggests: 1) the improvement of wrinkles with an amino acid sequence of SEQ ID NO: 1; 2) the improvement of skin elasticity with an amino acid sequence of SEQ ID NO: 1; 3) wound recovery with an amino acid sequence of SEQ ID NO: 1; 4) strengthening of skin barrier with SEQ ID NO: 1; and 5) inhibition of skin aging with SEQ ID NO: 1.
(D) The level of one of ordinary skill;
The skill of those skilled in the art is high.
(E) The level of predictability in the art;
Considering that no prior art was found that suggests: 1) the improvement of wrinkles with an amino acid sequence of SEQ ID NO: 1; 2) the improvement of skin elasticity with an amino acid sequence of SEQ ID NO: 1; 3) wound recovery with an amino acid sequence of SEQ ID NO: 1; 4) strengthening of skin barrier with SEQ ID NO: 1; and 5) inhibition of skin aging with SEQ ID NO: 1, the unpredictability of treatment as claimed is very high.
(F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The specification does not provide any examples with respect to: 1) the improvement of wrinkles with an amino acid sequence of SEQ ID NO: 1; 2) the improvement of skin elasticity with an amino acid sequence of SEQ ID NO: 1; 3) wound recovery with an amino acid sequence of SEQ ID NO: 1; 4) strengthening of skin barrier with SEQ ID NO: 1; and 5) inhibition of skin aging with SEQ ID NO: 1.
The MPEP (2164.02) states that " The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).” The MPEP further states that
PNG
media_image1.png
18
19
media_image1.png
Greyscale
“Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.”
In the instant application, the specification does not provide any guidance to allow for: 1) the improvement of wrinkles with an amino acid sequence of SEQ ID NO: 1; 2) the improvement of skin elasticity with an amino acid sequence of SEQ ID NO: 1; 3) wound recovery with an amino acid sequence of SEQ ID NO: 1; 4) strengthening of skin barrier with SEQ ID NO: 1; and 5) inhibition of skin aging with SEQ ID NO: 1.
Working examples are necessary since the art has indicated unpredictability of treatment of such diseases is very high.
Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the invention as claimed.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6-7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 is drawn to a cosmetic composition for improving a skin condition. it is noted that “[d]uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02). In the instant case, the limitation “for improving a skin condition" is an intended use. Therefore, claims 6-7, which are drawn to the result of said intended use, fail to further limit the subject matter of claim 5. 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 § 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 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hruby et al. (J Med Chem. 1987 Nov;30(11):2126-30).
With respect to claim 1, note that the claim language “consisting of an amino acid sequence of SEQ ID NO: 1” encompasses peptides that comprise the full-length sequence of SEQ ID NO: 1 or any portion of SEQ ID NO: 1.
Hruby et al. teach the peptide Ac-Phe-Arg-NH2 (abstract), which is a peptide consisting of an amino acid sequence of SEQ ID NO: 1 (i.e. the last three residues of SEQ ID NO: 1).
With respect to claims 2-3, the peptide of Hruby et al. comprises an acetyl group at the N-terminus, and an amino group at the C-terminus.
With respect to claim 4, the MPEP 2112.01 states that “'Products of identical chemical composition cannot have mutually exclusive properties.’ A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). In the instant case, the peptide of Hruby et al. is encompassed by the claimed peptide consisting of an amino acid sequence of SEQ ID NO: 1. Thus, it would inherently possess the same properties.
Furthermore, since the Office does not have the facilities for examining and comparing applicants’ peptide with the peptide of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the peptide of the prior art does not possess the same material structural and functional characteristics of the claimed peptide). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
With respect to claims 5-7, it is noted that “[d]uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02). In the instant case, the limitation “for improving a skin condition" does not appear to add any further structural differences that would distinguish the instant invention with regards to the invention of Hruby et al. Thus, Hruby et al. is deemed to anticipate these claims.
To overcome the rejection of claim 1, Applicant should amend the claim to recite “A peptide consisting of .
Claims 1 and 4-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cruz-Vera et al. (Nucleic Acids Res. 2004 Aug 18;32(15):4462–4468).
With respect to claim 1, note that the claim language “consisting of an amino acid sequence of SEQ ID NO: 1” encompasses peptides that comprise the full-length sequence of SEQ ID NO: 1 or any portion of SEQ ID NO: 1.
Cruz-Vera et al. teach the peptide Met-Arg-Arg (abstract), which is a peptide consisting of an amino acid sequence of SEQ ID NO: 1 (i.e. the last three residues of SEQ ID NO: 1).
With respect to claim 4, the MPEP 2112.01 states that “'Products of identical chemical composition cannot have mutually exclusive properties.’ A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). In the instant case, the peptide of Cruz-Vera et al. is encompassed by the claimed peptide consisting of an amino acid sequence of SEQ ID NO: 1. Thus, it would inherently possess the same properties.
Furthermore, since the Office does not have the facilities for examining and comparing applicants’ peptide with the peptide of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the peptide of the prior art does not possess the same material structural and functional characteristics of the claimed peptide). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
With respect to claims 5-7, it is noted that “[d]uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02). In the instant case, the limitation “for improving a skin condition" does not appear to add any further structural differences that would distinguish the instant invention with regards to the invention of Cruz-Vera et al. Thus, Cruz-Vera et al. is deemed to anticipate these claims.
To overcome the rejection of claim 1, Applicant should amend the claim to recite “A peptide consisting of
Allowable Subject Matter
A peptide consisting of SEQ ID NO: 1 is free of the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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, MELISSA FISHER can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
Prosecution Insights