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 .
Status of Claims
Claims 1-11 are pending and will be examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/285,605, filed on 04/15/2021.
Information Disclosure Statement
The Information Disclosure Statements filed on 08/08/2024 and 11/14/2024 have been considered. Signed copies are enclosed. Examiner notes that some copies of the foreign patents and non-patent literature are available in parent Application No. 17/285,605.
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.
Claims 2 and 4-10 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.
Claim 2 recites "a method for improvement in hair…". This is indefinite, as there is no definition or parameter provided for “improvement in hair”, and therefore one of ordinary skill in the art would not be able to tell the metes and bounds of the claim. Claim 3 resolves this indefiniteness as it recites that the improvement in hair includes hair growth promotion or hair loss suppression. However, dependent claims 4-10 do not resolve the indefiniteness of the claim and therefore inherit the rejection.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 7, and 11 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2014/0234337, Tsukamoto, published 08/21/2014 (hereinafter ‘337).
The instant claims are drawn to a method of manufacturing polyclonal antibodies, comprising immunizing ostriches with an immunogen from Staphylococcus aureus and Propionibacterium acne and purifying antibodies from the eggs of the immunized birds. Claim 11 further limits that the immunogen used to immunize the ostriches is a homogenate, or a lysis solution, of the bacteria. Claims 2-10 are drawn to a method of improvement in hair in a subject comprising administering the polyclonal antibodies to the skin of the subject, specifically the scalp, in the form of a shampoo or cosmetic product.
‘337 teaches a polyclonal bird antibody against a lysis solution of a microbial cell (see claims 1 and 2), wherein the bird is an ostrich (see claim 3) and the microbial cell is S. aureus and/or P. acne (see claims 4, 5, and paragraph [0040]), anticipating claims 1 and 11. ‘337 also teaches a method of treating skin of a subject, comprising administering the antibody to the subject (see claim 13), anticipating claim 4. While ‘337 does not discloses that this is a method for improving hair, as the method of ‘337 does not involve any distinct steps from the method of instant claim 2, and, as stated in the instant specification, pages 1-2, a skin has hair. Therefore, the step of applying the antibodies to the skin of a subject would necessarily result in improvement of hair, anticipating instant claim 2. The specification of ‘337 teaches that the antibodies were mixed into lotion and/or petrolatum (see paragraphs [0040] and [0060]) and applied to the skin, therefore are in the form of a cosmetic product, anticipating claim 7.
Therefore, ‘337 anticipates instant claims 1, 2, 4, 7, and 11.
Claim Rejections - 35 USC § 103
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, 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.
The factual inquiries 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.
Claim(s) 1-4, 7-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0234337, Tsukamoto, published 08/21/2014 in view of Barahmani et al. (2009) Journal of the American Academy of Dermatology, 61(4), 581-591 and Rongioletti et al. (2012) American journal of clinical dermatology, 13(4), 247-260.
The instant claims are drawn to a method of manufacturing polyclonal antibodies, comprising immunizing ostriches with an immunogen from Staphylococcus aureus and Propionibacterium acne and purifying antibodies from the eggs of the immunized birds. Claim 11 further limits that the immunogen used to immunize the ostriches is a homogenate, or a lysis solution, of the bacteria. Claims 2-10 are drawn to a method of improvement in hair in a subject comprising administering the polyclonal antibodies to the skin of the subject, specifically the scalp, in the form of a shampoo or cosmetic product.
‘337 teaches a polyclonal bird antibody against a lysis solution of a microbial cell (see claims 1 and 2), wherein the bird is an ostrich (see claim 3) and the microbial cell is S. aureus and/or P. acne (see claims 4, 5, and paragraph [0040]), teaching claims 1 and 11. ‘337 also teaches a method of treating skin of a subject, comprising administering the antibody to the subject (see claim 13), teaching claim 4. While ‘337 does not discloses that this is a method for improving hair, as the method of ‘337 does not involve any distinct steps from the method of instant claim 2, and, as stated in the instant specification, pages 1-2, a skin has hair. Therefore, the step of applying the antibodies to the skin of a subject would necessarily result in improvement of hair, teaching instant claim 2. The specification of ‘337 teaches that the antibodies were mixed into lotion and/or petrolatum (see paragraphs [0040] and [0060]) and applied to the skin, therefore are in the form of a cosmetic product, teaching claim 7.
‘337 does not explicitly teach applying the antibodies specifically to the scalp or administering the antibodies to a man or a woman, or that the improvement in hair includes hair growth promotion or hair loss suppression. However, ‘337 does teach that the antibodies can effectively inhibit proliferation of bacteria (see paragraph [0018] and Figure 2). Additionally, ‘337 teaches the administration to those with acne or atopy.
Barahmani et al. and Rongioletti et al. review the current understanding of alopecia in humans, disclosing there is no known cure. Barahmani et al. teach that there is an increased risk of alopecia areata in patients with history of any atopy (see abstract, whole document), and especially with a history of atopic dermatitis (see page 587). Barahmani et al. also teach that both men and women suffer from this correlation. Rongioletti et al. teach that certain etymologies of alopecia, such as Folliculitis Decalvans, is commonly associated with S. aureus, which is thought to be implicated in the disease pathogenesis (see page 255). Rongioletti et al. further teach that the full understanding of scarring alopecias remain unresolved (page 249) and that hair loss has a strong negative impact on patients’ psychology and quality of life (page 249-250).
Taken together, before the effective filing date of the claimed invention, one of ordinary skill in the art of hair improvement would recognize that S. aureus or P. acne antibodies, which successfully target bacterial infection, such as those in ‘337, would be potential treatments for alopecia. One would be motivated to use such an antibody as it is known to be safe and effective and would target a known contributor to disease pathogenesis. One would have a reasonable expectation of success as the antibodies are known in the art to work (see ‘337 figure 2) and are applied to skin (see ‘337 paragraph [0040]). Additionally, there is a reasonable expectation that there is an overlap in populations between those receiving the antibodies of ‘337 (those with atopy) and those needing treatment for hair improvement (those with alopecia) (see Barahmani et al.). Therefore, one of ordinary skill in the art would be motivated to use the treatment method of ‘337 on men and women to improve hair.
Claim(s) 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0234337, Tsukamoto, published 08/21/2014 in view of Barahmani et al. and Rongioletti et al. as applied to claims 1-4, 7-9, and 11 above, and further in view of US 2016/0297894, Tsukamoto, published 10/13/2016 (hereinafter '894).
The teachings of ‘337 and Barahmani et al. and Rongioletti et al. regarding claims 1-4, 7-9, and 11 are discussed above, under paragraph 12. ‘337 does not explicitly teach applying the method to the skin of a scalp, in the form of shampoo, conditioner, or wax, or further comprising administering to the subject minoxidil, adenosine-related compound, or 3'-phosphoadenosine-5'-phosphosulfate.
‘894 does teach a method of administering antibodies for hair production and/or hair growth (see claim 7). ‘894 also teaches a method of manufacturing a hair loss-suppressing antibody, comprising: inoculating a female ostrich with a hair loss-inducing substance; and purifying an antibody from an egg laid by the female ostrich (claim 1). As evidenced by Rongioletti et al., S. aureus is a hair-loss inducing substance, and immunizing an ostrich with an immunogen of S. aureus is encompassed in this claim. Claim 11 recites that the antibodies are administered in the form of a haircare product, and paragraph [0012] and claim 15 recite that the product may be shampoo, hair treatment agent, pharmaceutical products such as a hair growth agent, hair washing agent, or hair styling agent, teaching instant claim 6. ‘894 also teaches that the antibodies are administered to the scalp (see abstract), teaching instant claim 5. Finally, paragraph [0017] of ‘894 recites that the antibodies may be concurrently administered with minoxidil, adenosine-related compound, or 3'-phosphoadenosine-5'-phosphosulfate, which are known hair growth agents.
Taken together, ‘894 clearly teaches the instant limitations absent in ‘337. While ‘894 does not specifically teach antibodies to S. aureus or P. acne, Barahmani et al. and Rongioletti et al. provide clear motivation to use the antibodies of ‘337 for a method of improving hair. As ‘894 discloses a similar method to that of ‘337, it would be obvious to one of ordinary skill in the art to use the antibodies disclosed in ‘337 with the method and product limitations of ‘894 to better treat alopecia. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that a claim would have been obvious if 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. As both ‘337 and ‘894 are in the same field of manufacturing polyclonal ostrich antibodies for skin treatment, there is a need for alopecia treatment (see Rongioletti et al. and ‘894, paragraph [0002]), and the link between alopecia and atopy is known in the art, it would be obvious to apply the antibodies of ‘337 via the method of ‘894 in order to treat alopecia and yield predictable results. Thus, the combination of prior art references as combined provided a prima facie case of obviousness, absent convincing evidence to the contrary.
Therefore, claims 1-11 are obvious over ‘337 and ‘894 in view of Barahmani et al. and Rongioletti et al.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amelia Stephens whose telephone number is (571)272-1006. 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, Anne Gussow can be reached at (571) 272-6047. 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.
/AMELIA STEPHENS/Examiner, Art Unit 1645
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
Prosecution Insights